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Table representation of search results timeline featuring number of search results per year.

Year Number of Results
1966 9
1967 6
1968 8
1969 10
1970 7
1971 7
1972 6
1973 12
1974 9
1975 10
1976 17
1977 18
1978 17
1979 23
1980 24
1981 31
1982 26
1983 43
1984 38
1985 55
1986 57
1987 61
1988 44
1989 47
1990 72
1991 82
1992 76
1993 79
1994 94
1995 101
1996 68
1997 111
1998 99
1999 97
2000 87
2001 96
2002 94
2003 83
2004 80
2005 102
2006 87
2007 89
2008 114
2009 108
2010 97
2011 104
2012 115
2013 151
2014 113
2015 117
2016 93
2017 82
2018 105
2019 81
2020 84
2021 89
2022 71
2023 59
2024 36

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3,505 results

Results by year

Filters applied: Randomized Controlled Trial, Infant: birth-23 months. Clear all
Page 1
Dupilumab for Eosinophilic Esophagitis in Patients 1 to 11 Years of Age.
Chehade M, Dellon ES, Spergel JM, Collins MH, Rothenberg ME, Pesek RD, Hirano I, Liu R, Laws E, Mortensen E, Martincova R, Shabbir A, McCann E, Kamal MA, Kosloski MP, Hamilton JD, Samuely C, Lim WK, Wipperman MF, Farrell A, Patel N, Yancopoulos GD, Glotfelty L, Maloney J. Chehade M, et al. N Engl J Med. 2024 Jun 27;390(24):2239-2251. doi: 10.1056/NEJMoa2312282. N Engl J Med. 2024. PMID: 38924731 Clinical Trial.
Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.
Tumukunde V, Medvedev MM, Tann CJ, Mambule I, Pitt C, Opondo C, Kakande A, Canter R, Haroon Y, Kirabo-Nagemi C, Abaasa A, Okot W, Katongole F, Ssenyonga R, Niombi N, Nanyunja C, Elbourne D, Greco G, Ekirapa-Kiracho E, Nyirenda M, Allen E, Waiswa P, Lawn JE; OMWaNA Collaborative Authorship Group. Tumukunde V, et al. Lancet. 2024 Jun 8;403(10443):2520-2532. doi: 10.1016/S0140-6736(24)00064-3. Epub 2024 May 13. Lancet. 2024. PMID: 38754454 Free article. Clinical Trial.
INTERPRETATION: KMC initiated before stabilisation did not reduce early neonatal mortality; however, it was cost-effective from the societal and provider perspectives compared with standard care. Additional investment in neonatal care is needed for inc …
INTERPRETATION: KMC initiated before stabilisation did not reduce early neonatal mortality; however, it was cost-effective from the s …
Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants.
Geraghty LE, Dunne EA, Ní Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Geraghty LE, et al. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5. N Engl J Med. 2024. PMID: 38709215 Clinical Trial.
The use of a video laryngoscope, which has a camera at the tip of the blade that displays a view of the airway on a screen, has been associated with a greater percentage of successful intubations on the first attempt than the use of direct laryngoscopy in adults and children. The …
The use of a video laryngoscope, which has a camera at the tip of the blade that displays a view of the airway on a screen, has been associa …
Advance Care Planning for Children With Rare Diseases: A Pilot RCT.
Lyon ME, Fraser JL, Thompkins JD, Clark H, Brodie N, Detwiler K, Torres C, Guerrera MF, Younge T, Aoun S, Trujillo Rivera EA. Lyon ME, et al. Pediatrics. 2024 Jun 1;153(6):e2023064557. doi: 10.1542/peds.2023-064557. Pediatrics. 2024. PMID: 38699801 Clinical Trial.
Investigators assessed the initial efficacy of the FAmily CEntered (FACE) pediatric advance care planning (pACP), FACE-Rare, intervention on families' quality of life. ...Outcome measures were Beck Anxiety Inventory, Family Appraisal of Caregiving, Functional Assessment of …
Investigators assessed the initial efficacy of the FAmily CEntered (FACE) pediatric advance care planning (pACP), FACE-Rare, interven …
A measles and rubella vaccine microneedle patch in The Gambia: a phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial.
Adigweme I, Yisa M, Ooko M, Akpalu E, Bruce A, Donkor S, Jarju LB, Danso B, Mendy A, Jeffries D, Segonds-Pichon A, Njie A, Crooke S, El-Badry E, Johnstone H, Royals M, Goodson JL, Prausnitz MR, McAllister DV, Rota PA, Henry S, Clarke E. Adigweme I, et al. Lancet. 2024 May 11;403(10439):1879-1892. doi: 10.1016/S0140-6736(24)00532-4. Epub 2024 Apr 29. Lancet. 2024. PMID: 38697170 Free PMC article. Clinical Trial.
To be eligible, all participants had to be healthy according to prespecified criteria, aged 18-40 years for the adult cohort, 15-18 months for toddlers, or 9-10 months for infants, and to be available for visits throughout the follow-up period. ...Induration at the MRV-MNP …
To be eligible, all participants had to be healthy according to prespecified criteria, aged 18-40 years for the adult cohort, 15-18 months f …
Nutritional Support for Moderate-to-Late-Preterm Infants - A Randomized Trial.
Alexander T, Asadi S, Meyer M, Harding JE, Jiang Y, Alsweiler JM, Muelbert M, Bloomfield FH; DIAMOND Trial Group. Alexander T, et al. N Engl J Med. 2024 Apr 25;390(16):1493-1504. doi: 10.1056/NEJMoa2313942. N Engl J Med. 2024. PMID: 38657245 Clinical Trial.
BACKGROUND: Most moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother's breast milk. ...Secondary outcomes were similar across interventions. Serious adverse events occurred in one infant. CONCLUSIONS: T …
BACKGROUND: Most moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother' …
Feasibility, safety, and impact of the RTS,S/AS01E malaria vaccine when implemented through national immunisation programmes: evaluation of cluster-randomised introduction of the vaccine in Ghana, Kenya, and Malawi.
Asante KP, Mathanga DP, Milligan P, Akech S, Oduro A, Mwapasa V, Moore KA, Kwambai TK, Hamel MJ, Gyan T, Westercamp N, Kapito-Tembo A, Njuguna P, Ansong D, Kariuki S, Mvalo T, Snell P, Schellenberg D, Welega P, Otieno L, Chimala A, Afari EA, Bejon P, Maleta K, Agbenyega T, Snow RW, Zulu M, Chinkhumba J, Samuels AM; Malaria Vaccine Programme Evaluation Partners. Asante KP, et al. Lancet. 2024 Apr 27;403(10437):1660-1670. doi: 10.1016/S0140-6736(24)00004-7. Epub 2024 Apr 4. Lancet. 2024. PMID: 38583454 Free article. Clinical Trial.
The Injury Prevention Program to Reduce Early Childhood Injuries: A Cluster Randomized Trial.
Perrin EM, Skinner AC, Sanders LM, Rothman RL, Schildcrout JS, Bian A, Barkin SL, Coyne-Beasley T, Delamater AM, Flower KB, Heerman WJ, Steiner MJ, Yin HS. Perrin EM, et al. Pediatrics. 2024 May 1;153(5):e2023062966. doi: 10.1542/peds.2023-062966. Pediatrics. 2024. PMID: 38557871 Clinical Trial.
Proportional odds logistic regression analyses with generalized estimating equation examined the extent to which the number of injuries reported were reduced at TIPP intervention sites compared with control sites, adjusting for baseline child, parent, and household factors. RESUL …
Proportional odds logistic regression analyses with generalized estimating equation examined the extent to which the number of injuries repo …
Effect of Early vs Late Inguinal Hernia Repair on Serious Adverse Event Rates in Preterm Infants: A Randomized Clinical Trial.
HIP Trial Investigators; Blakely ML, Krzyzaniak A, Dassinger MS, Pedroza C, Weitkamp JH, Gosain A, Cotten M, Hintz SR, Rice H, Courtney SE, Lally KP, Ambalavanan N, Bendel CM, Bui KCT, Calkins C, Chandler NM, Dasgupta R, Davis JM, Deans K, DeUgarte DA, Gander J, Jackson CA, Keszler M, Kling K, Fenton SJ, Fisher KA, Hartman T, Huang EY, Islam S, Koch F, Lainwala S, Lesher A, Lopez M, Misra M, Overbey J, Poindexter B, Russell R, Stylianos S, Tamura DY, Yoder BA, Lucas D, Shaul D, Ham PB 3rd, Fitzpatrick C, Calkins K, Garrison A, de la Cruz D, Abdessalam S, Kvasnovsky C, Segura BJ, Shilyansky J, Smith LM, Tyson JE. HIP Trial Investigators, et al. JAMA. 2024 Mar 26;331(12):1035-1044. doi: 10.1001/jama.2024.2302. JAMA. 2024. PMID: 38530261 Clinical Trial.
Whether the inguinal hernia should be repaired prior to or after discharge from the neonatal intensive care unit is controversial. OBJECTIVE: To evaluate the safety of early vs late surgical repair for preterm infants with an inguinal hernia. .. …
Whether the inguinal hernia should be repaired prior to or after discharge from the neonatal intensive care unit is con …
Efficacy of Early Intervention for Infants With Cerebral Palsy in an LMIC: An RCT.
Benfer KA, Whittingham K, Ware RS, Ghosh AK, Chowdhury S, Moula G, Samanta S, Khan NZ, Bell KL, Oftedal S, Bandaranayake S, Salt AT, Bhattacharya A, Maiti P, Tripathi SK, Morgan C, Novak I, Boyd RN. Benfer KA, et al. Pediatrics. 2024 Apr 1;153(4):e2023063854. doi: 10.1542/peds.2023-063854. Pediatrics. 2024. PMID: 38516717 Clinical Trial.
OBJECTIVE: To test efficacy of a parent-delivered multidomain early intervention (Learning through Everyday Activities with Parents [LEAP-CP]) for infants with cerebral palsy (CP) compared with equal-dose of health advice (HA), on (1) infant development; and (2) car …
OBJECTIVE: To test efficacy of a parent-delivered multidomain early intervention (Learning through Everyday Activities with Parents [LEAP-CP …
Neonatal Ultrasound and Radiographic Markers of Hip Dysplasia in Young Adults.
Laborie LB, Rasmussen H, Jacobsen KK, Gundersen T, Rosendahl K. Laborie LB, et al. Pediatrics. 2024 Apr 1;153(4):e2023064564. doi: 10.1542/peds.2023-064564. Pediatrics. 2024. PMID: 38501191 Clinical Trial.
OBJECTIVES: To examine radiologic outcomes at skeletal maturity of sonographically normal, immature, mildly, and severely dysplastic newborn hips. METHODS: During 1988 to 1990, 11 925 newborns were enrolled in a randomized controlled trial examining screening strate …
OBJECTIVES: To examine radiologic outcomes at skeletal maturity of sonographically normal, immature, mildly, and severely dysplastic newb
Optimised prevention of postnatal HIV transmission in Zambia and Burkina Faso (PROMISE-EPI): a phase 3, open-label, randomised controlled trial.
Kankasa C, Mennecier A, Sakana BLD, Molès JP, Mwiya M, Chunda-Liyoka C, D'Ottavi M, Tassembedo S, Wilfred-Tonga MM, Fao P, Rutagwera D, Matoka B, Kania D, Taofiki OA, Tylleskär T, Van de Perre P, Nagot N; PROMISE-EPI Trial Group. Kankasa C, et al. Lancet. 2024 Apr 6;403(10434):1362-1371. doi: 10.1016/S0140-6736(23)02464-9. Epub 2024 Mar 11. Lancet. 2024. PMID: 38484756 Clinical Trial.
Mothers with HIV and their breastfed infants without HIV attending the second visit of the Expanded Programme of Immunisation (EPI-2; infant age 6-8 weeks) were randomly assigned 1:1 to intervention or control groups. ...The primary outcome assessed by modified inte …
Mothers with HIV and their breastfed infants without HIV attending the second visit of the Expanded Programme of Immunisation (EPI-2; …
Effect of Minimization of Early Blood Sampling Losses Among Extremely Premature Neonates: A Randomized Clinical Trial.
Balasubramanian H, Bhanushali M, Tripathi V, Srinivasan L, Sakharkar S, Pillai A, Kabra NS. Balasubramanian H, et al. J Pediatr. 2024 Jun;269:114002. doi: 10.1016/j.jpeds.2024.114002. Epub 2024 Mar 4. J Pediatr. 2024. PMID: 38447757 Clinical Trial.
The RS group had a significantly lower rate of early postnatal RBC transfusions (41% vs 73%, RR: 0.56 [0.39-0.81], P = .001). The hazard of needing a transfusion during neonatal intensive care unit (NICU) stay was reduced by 55% by RS. Mortality and …
The RS group had a significantly lower rate of early postnatal RBC transfusions (41% vs 73%, RR: 0.56 [0.39-0.81], P = .001). The hazard of …
Omalizumab for the Treatment of Multiple Food Allergies.
Wood RA, Togias A, Sicherer SH, Shreffler WG, Kim EH, Jones SM, Leung DYM, Vickery BP, Bird JA, Spergel JM, Iqbal A, Olsson J, Ligueros-Saylan M, Uddin A, Calatroni A, Huckabee CM, Rogers NH, Yovetich N, Dantzer J, Mudd K, Wang J, Groetch M, Pyle D, Keet CA, Kulis M, Sindher SB, Long A, Scurlock AM, Lanser BJ, Lee T, Parrish C, Brown-Whitehorn T, Spergel AKR, Veri M, Hamrah SD, Brittain E, Poyser J, Wheatley LM, Chinthrajah RS. Wood RA, et al. N Engl J Med. 2024 Mar 7;390(10):889-899. doi: 10.1056/NEJMoa2312382. Epub 2024 Feb 25. N Engl J Med. 2024. PMID: 38407394 Clinical Trial.
Safety of the novel oral poliovirus vaccine type 2 (nOPV2) in infants and young children aged 1 to <5 years and lot-to-lot consistency of the immune response to nOPV2 in infants in The Gambia: a phase 3, double-blind, randomised controlled trial.
Ochoge M, Futa AC, Umesi A, Affleck L, Kotei L, Daffeh B, Saidy-Jah E, Njie A, Oyadiran O, Edem B, Jallow M, Jallow E, Donkor SA, Tritama E, Abid T, Jones KAV, Mainou BA, Konz JO, Fix A, Gast C, Clarke E. Ochoge M, et al. Lancet. 2024 Mar 23;403(10432):1164-1175. doi: 10.1016/S0140-6736(23)02844-1. Epub 2024 Feb 22. Lancet. 2024. PMID: 38402887 Free PMC article. Clinical Trial.
Infants randomly assigned to receive one or two doses of one of three lots of nOPV2 or one lot of bivalent OPV (bOPV). ...INTERPRETATION: nOPV2 was immunogenic and safe in infants and young children in The Gambia. The data support the licensure and WHO prequalificat
Infants randomly assigned to receive one or two doses of one of three lots of nOPV2 or one lot of bivalent OPV (bOPV). ...INTERPRETAT
Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials.
Wagenlehner F, Perry CR, Hooton TM, Scangarella-Oman NE, Millns H, Powell M, Jarvis E, Dennison J, Sheets A, Butler D, Breton J, Janmohamed S. Wagenlehner F, et al. Lancet. 2024 Feb 24;403(10428):741-755. doi: 10.1016/S0140-6736(23)02196-7. Epub 2024 Feb 8. Lancet. 2024. PMID: 38342126 Clinical Trial.
The primary endpoint, therapeutic response (success or failure) at test-of-cure (ie, day 10-13), was evaluated in randomly assigned patients with nitrofurantoin-susceptible qualifying uropathogens (10(5) colony-forming units [CFU] per mL) and who received at least one dose …
The primary endpoint, therapeutic response (success or failure) at test-of-cure (ie, day 10-13), was evaluated in randomly assigned patients …
Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial.
Datoo MS, Dicko A, Tinto H, Ouédraogo JB, Hamaluba M, Olotu A, Beaumont E, Ramos Lopez F, Natama HM, Weston S, Chemba M, Compaore YD, Issiaka D, Salou D, Some AM, Omenda S, Lawrie A, Bejon P, Rao H, Chandramohan D, Roberts R, Bharati S, Stockdale L, Gairola S, Greenwood BM, Ewer KJ, Bradley J, Kulkarni PS, Shaligram U, Hill AVS; R21/Matrix-M Phase 3 Trial Group. Datoo MS, et al. Lancet. 2024 Feb 10;403(10426):533-544. doi: 10.1016/S0140-6736(23)02511-4. Epub 2024 Feb 1. Lancet. 2024. PMID: 38310910 Free article. Clinical Trial.
Esophageal Versus Rectal Temperature Monitoring During Whole-Body Therapeutic Hypothermia for Hypoxic-Ischemic Encephalopathy: Association with Short- and Long-Term Outcomes.
Wu TW, Schmicker R, Wood TR, Mietzsch U, Comstock B, Heagerty PJ, Rao R, Gonzalez F, Juul S, Wu YW. Wu TW, et al. J Pediatr. 2024 May;268:113933. doi: 10.1016/j.jpeds.2024.113933. Epub 2024 Feb 1. J Pediatr. 2024. PMID: 38309524 Free article. Clinical Trial.
OBJECTIVE: To compare the short- and long-term outcomes of infants with hypoxic-ischemic encephalopathy (HIE) treated with whole-body therapeutic hypothermia (TH), monitored by esophageal vs rectal temperature. STUDY DESIGN: We conducted a secondary analysis of the multice …
OBJECTIVE: To compare the short- and long-term outcomes of infants with hypoxic-ischemic encephalopathy (HIE) treated with whole-body …
Oral Valganciclovir Initiated Beyond 1 Month of Age as Treatment of Sensorineural Hearing Loss Caused by Congenital Cytomegalovirus Infection: A Randomized Clinical Trial.
Kimberlin DW, Aban I, Peri K, Nishikawa JK, Bernatoniene J, Emonts M, Klein N, Bamford A, DeBiasi RL, Faust SN, Jones CE, McMaster P, Caserta M, Ahmed A, Sharland M, Demmler-Harrison G, Hackett S, Sánchez PJ, Shackley F, Kelly D, Dennehy PH, Storch GA, Whitley RJ, Griffiths P; Collaborative Antiviral Study Group (CASG). Kimberlin DW, et al. J Pediatr. 2024 May;268:113934. doi: 10.1016/j.jpeds.2024.113934. Epub 2024 Feb 2. J Pediatr. 2024. PMID: 38309519 Clinical Trial.
Dextrose gel prophylaxis for neonatal hypoglycaemia and neurocognitive function at early school age: a randomised dosage trial.
Wei X, Franke N, Alsweiler JM, Brown GTL, Gamble GD, McNeill A, Rogers J, Thompson B, Turuwhenua J, Wouldes TA, Harding JE, McKinlay CJD; pre-hPOD Early School-age Outcomes Study Group. Wei X, et al. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):421-427. doi: 10.1136/archdischild-2023-326452. Arch Dis Child Fetal Neonatal Ed. 2024. PMID: 38307710 Clinical Trial.
PATIENTS: Children born at 35 weeks with 1 risk factor for neonatal hypoglycaemia: maternal diabetes, small or large for gestational age, or late preterm. ...Children exposed to any dose of dextrose gel (combined), compared with placebo, had a lower risk of motor im …
PATIENTS: Children born at 35 weeks with 1 risk factor for neonatal hypoglycaemia: maternal diabetes, small or large for gestational …
Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.
Gupta S, Subhedar NV, Bell JL, Field D, Bowler U, Hutchison E, Johnson S, Kelsall W, Pepperell J, Roberts T, Sinha S, Stanbury K, Wyllie J, Hardy P, Juszczak E; Baby-OSCAR Collaborative Group. Gupta S, et al. N Engl J Med. 2024 Jan 25;390(4):314-325. doi: 10.1056/NEJMoa2305582. N Engl J Med. 2024. PMID: 38265644 Free PMC article. Clinical Trial.
BACKGROUND: The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known. ...A total of 44 of 323 infan
BACKGROUND: The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whe …
Azithromycin during Routine Well-Infant Visits to Prevent Death.
Sié A, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Compaoré G, Dah C, Bagagnan C, Lebas E, Hu H, Rice J, Porco TC, Arnold BF, Lietman TM, Oldenburg CE. Sié A, et al. N Engl J Med. 2024 Jan 18;390(3):221-229. doi: 10.1056/NEJMoa2309495. N Engl J Med. 2024. PMID: 38231623 Clinical Trial.
BACKGROUND: Mass distribution of azithromycin to children 1 to 59 months of age has been shown to reduce childhood all-cause mortality in some sub-Saharan African regions, with the largest reduction seen among infants younger than 12 months of age. Whether the administrati …
BACKGROUND: Mass distribution of azithromycin to children 1 to 59 months of age has been shown to reduce childhood all-cause mortality in so …
Sustained inflation and chest compression versus 3:1 chest compression to ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns (SURV1VE): A cluster randomised controlled trial.
Schmölzer GM, Pichler G, Solevåg AL, Law BHY, Mitra S, Wagner M, Pfurtscheller D, Yaskina M, Cheung PY; SURV1VE- Trial Investigators. Schmölzer GM, et al. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):428-435. doi: 10.1136/archdischild-2023-326383. Arch Dis Child Fetal Neonatal Ed. 2024. PMID: 38212104 Free PMC article. Clinical Trial.
SETTING: DR in four hospitals in Canada and Austria, PARTICIPANTS: Newborn infants >28 weeks' gestation who required CC. INTERVENTIONS: Hospitals were randomised to CC+SI or 3:1 C:V then crossed over to the other intervention. ...All 11 infants in the CC+S …
SETTING: DR in four hospitals in Canada and Austria, PARTICIPANTS: Newborn infants >28 weeks' gestation who required CC. IN …
Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants.
Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Felter CT, Vassilouthis NC, Jin J, Bangert M, Mari K, Nteene R, Wague S, Roberts M, Tissières P, Royal S, Faust SN; HARMONIE Study Group. Drysdale SB, et al. N Engl J Med. 2023 Dec 28;389(26):2425-2435. doi: 10.1056/NEJMoa2309189. N Engl J Med. 2023. PMID: 38157500 Clinical Trial.
A key secondary end point was very severe RSV-associated lower respiratory tract infection, defined as hospitalization for RSV-associated lower respiratory tract infection with an oxygen saturation of less than 90% and the need for supplemental oxygen. RESULTS: A total of 8058 …
A key secondary end point was very severe RSV-associated lower respiratory tract infection, defined as hospitalization for RSV-associated lo …
Feasibility and Safety of Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia (SANE-01): A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Trial.
Wintermark P, Lapointe A, Steinhorn R, Rampakakis E, Burhenne J, Meid AD, Bajraktari-Sylejmani G, Khairy M, Altit G, Adamo MT, Poccia A, Gilbert G, Saint-Martin C, Toffoli D, Vachon J, Hailu E, Colin P, Haefeli WE. Wintermark P, et al. J Pediatr. 2024 Mar;266:113879. doi: 10.1016/j.jpeds.2023.113879. Epub 2023 Dec 22. J Pediatr. 2024. PMID: 38142044 Free article. Clinical Trial.
OBJECTIVE: To test feasibility and safety of administering sildenafil in neonates with neonatal encephalopathy (NE), developing brain injury despite therapeutic hypothermia (TH). ...Sildenafil plasma steady-state concentration was rapidly reached, but decreased afte …
OBJECTIVE: To test feasibility and safety of administering sildenafil in neonates with neonatal encephalopathy (NE), developin …
Early and exclusive enteral nutrition in infants born very preterm.
Razzaghy J, Shukla VV, Gunawan E, Reeves A, Nguyen K, Salas AA. Razzaghy J, et al. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):378-383. doi: 10.1136/archdischild-2023-325969. Arch Dis Child Fetal Neonatal Ed. 2024. PMID: 38135494 Clinical Trial.
OBJECTIVE: To characterise the effects of early and exclusive enteral nutrition with either maternal or donor milk in infants born very preterm (28(0/7)-32(6/7) weeks of gestation). DESIGN: Parallel-group, unmasked randomised controlled trial. SETTING: Regional, ter …
OBJECTIVE: To characterise the effects of early and exclusive enteral nutrition with either maternal or donor milk in infants born ve …
Randomised crossover study on pulse oximeter readings from different sensors in very preterm infants.
Maiwald CA, Schwarz CE, Böckmann K, Springer L, Poets CF, Franz A. Maiwald CA, et al. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):391-396. doi: 10.1136/archdischild-2023-325961. Arch Dis Child Fetal Neonatal Ed. 2024. PMID: 38129130 Free PMC article. Clinical Trial.
OBJECTIVE: In extremely preterm infants, different target ranges for pulse oximeter saturation (SpO(2)) may affect mortality and morbidity. ...DESIGN: Single-centre, randomised, triple crossover study. SETTING: Tertiary neonatal intensive care u …
OBJECTIVE: In extremely preterm infants, different target ranges for pulse oximeter saturation (SpO(2)) may affect mortality a …
Evolution of the Sarnat exam and association with 2-year outcomes in infants with moderate or severe hypoxic-ischaemic encephalopathy: a secondary analysis of the HEAL Trial.
Mietzsch U, Kolnik SE, Wood TR, Natarajan N, Gonzalez FF, Glass H, Mayock DE, Bonifacio SL, Van Meurs K, Comstock BA, Heagerty PJ, Wu TW, Wu YW, Juul SE; HEAL Trial Study Group. Mietzsch U, et al. Arch Dis Child Fetal Neonatal Ed. 2024 Apr 18;109(3):308-316. doi: 10.1136/archdischild-2023-326102. Arch Dis Child Fetal Neonatal Ed. 2024. PMID: 38071538 Free PMC article. Clinical Trial.
OBJECTIVE: To study the association between the Sarnat exam (SE) performed before and after therapeutic hypothermia (TH) and outcomes at 2 years in infants with moderate or severe hypoxic-ischaemic encephalopathy (HIE). ...CONCLUSION: Both rSE and change between qSE and rS …
OBJECTIVE: To study the association between the Sarnat exam (SE) performed before and after therapeutic hypothermia (TH) and outcomes at 2 y …
Effect of Systemic Hydrocortisone on Brain Abnormalities and Regional Brain Volumes in Ventilator-dependent Infants Born Preterm: Substudy of the SToP-BPD Study.
Halbmeijer NM, Onland W, Dudink J, Cools F, Debeer A, van Kaam AH, Benders MJNL, van der Aa NE. Halbmeijer NM, et al. J Pediatr. 2024 Feb;265:113807. doi: 10.1016/j.jpeds.2023.113807. Epub 2023 Nov 1. J Pediatr. 2024. PMID: 37923196 Free article. Clinical Trial.
OBJECTIVE: To evaluate whether a high cumulative dose of systemic hydrocortisone affects brain development compared with placebo when initiated between 7 and 14 days after birth in ventilated infants born preterm. STUDY DESIGN: A double-blind, placebo-controlled, ra …
OBJECTIVE: To evaluate whether a high cumulative dose of systemic hydrocortisone affects brain development compared with placebo when initia …
2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial.
Clarke P, Soe A, Nichols A, Harizaj H, Webber MA, Linsell L, Bell JL, Tremlett C, Muthukumar P, Pattnayak S, Partlett C, King A, Juszczak E, Heath PT. Clarke P, et al. Arch Dis Child Fetal Neonatal Ed. 2024 Feb 19;109(2):202-210. doi: 10.1136/archdischild-2023-325871. Arch Dis Child Fetal Neonatal Ed. 2024. PMID: 37907266 Free PMC article. Clinical Trial.
DESIGN: Feasibility RCT. SETTING: Two UK tertiary-level neonatal intensive care units. PATIENTS: Preterm infants born <34 weeks' gestation scheduled to undergo PCVC insertion. ...ARCTIC provides preliminary reassurance supporting poten …
DESIGN: Feasibility RCT. SETTING: Two UK tertiary-level neonatal intensive care units. PATIENTS: Preterm
Real-Time Digital Feedback Device and Simulated Newborn Ventilation Quality.
Data S, Nelson BD, Cedrone K, Mwebesa W, Engol S, Nsiimenta N, Olson KR. Data S, et al. Pediatrics. 2023 Nov 1;152(5):e2022060599. doi: 10.1542/peds.2022-060599. Pediatrics. 2023. PMID: 37873596 Clinical Trial.
OBJECTIVES: Effective bag-valve-mask ventilation is critical for reducing perinatal asphyxia-related neonatal deaths; however, providers often fail to achieve and maintain effective ventilation. The Augmented Infant Resuscitator (AIR) attaches to bag-valve-masks and …
OBJECTIVES: Effective bag-valve-mask ventilation is critical for reducing perinatal asphyxia-related neonatal deaths; however, provid …
Prolonged use of closed-loop inspired oxygen support in preterm infants: a randomised controlled trial.
Schouten TMR, Abu-Hanna A, van Kaam AH, van den Heuvel MEN, Bachman TE, van Leuteren RW, Hutten GJ, Onland W. Schouten TMR, et al. Arch Dis Child Fetal Neonatal Ed. 2024 Feb 19;109(2):221-226. doi: 10.1136/archdischild-2023-325831. Arch Dis Child Fetal Neonatal Ed. 2024. PMID: 37827816 Clinical Trial.
DESIGN: A single-centre randomised control trial. SETTING: A level III neonatal intensive care unit. PATIENTS: Preterm infants (<28 weeks' gestation) on non-invasive respiratory support. ...CONCLUSION: A-FiO(2) control was superior to manual …
DESIGN: A single-centre randomised control trial. SETTING: A level III neonatal intensive care unit. PATIENTS: Prete
Effects of a Parenting and Nutrition Intervention on Siblings: A Cluster-RCT.
Jeong J, Domonko V, Mendile T, Yousafzai AK. Jeong J, et al. Pediatrics. 2023 Oct 1;152(4):e2023061383. doi: 10.1542/peds.2023-061383. Pediatrics. 2023. PMID: 37777643 Clinical Trial.
Interventions encompassed various content including responsive parenting, infant and young child feeding, and positive couples' relationships. ...
Interventions encompassed various content including responsive parenting, infant and young child feeding, and positive couples' relat …
Volume-targeted mask ventilation during simulated neonatal resuscitation.
Law BHY, Schmölzer GM. Law BHY, et al. Arch Dis Child Fetal Neonatal Ed. 2024 Feb 19;109(2):217-220. doi: 10.1136/archdischild-2023-325902. Arch Dis Child Fetal Neonatal Ed. 2024. PMID: 37775257 Clinical Trial.
To aid mask PPV, stand-alone respiratory function monitors (RFMs) have been used in the delivery room, while ventilator-based, volume-targeted ventilation (VTV) is routinely used in the neonatal intensive care unit (NICU). DESIGN: This is a prospective …
To aid mask PPV, stand-alone respiratory function monitors (RFMs) have been used in the delivery room, while ventilator-based, volume-target …
Identifying effect modifiers of systemic hydrocortisone treatment initiated 7-14 days after birth in ventilated very preterm infants on long-term outcome: secondary analysis of a randomised controlled trial.
Halbmeijer NM, Sonnaert M, Swarte RM, Koopman-Esseboom C, van Stuijvenberg M, Mulder-de Tollenaer S, Tan RNGB, Mohns T, Bruneel E, Steiner K, Kramer BW, Debeer A, van Weissenbruch MM, Marechal Y, Blom H, Plaskie K, Offringa M, Merkus MP, Onland W, Leemhuis AG, van Kaam AH; SToP-BPD Study group. Halbmeijer NM, et al. Arch Dis Child Fetal Neonatal Ed. 2024 Feb 19;109(2):159-165. doi: 10.1136/archdischild-2023-325558. Arch Dis Child Fetal Neonatal Ed. 2024. PMID: 37722765 Clinical Trial.
OBJECTIVE: To explore clinical effect modifiers of systemic hydrocortisone in ventilated very preterm infants for survival and neurodevelopmental outcome at 2 years' corrected age (CA). DESIGN: Secondary analysis of a randomised placebo-controlled trial. SETTING: Du …
OBJECTIVE: To explore clinical effect modifiers of systemic hydrocortisone in ventilated very preterm infants for survival and …
A Randomized Controlled Trial of a Neonatal Intensive Care Unit Language Intervention for Parents of Preterm Infants and 2-Year Language Outcomes.
McGowan EC, Caskey M, Tucker R, Vohr BR. McGowan EC, et al. J Pediatr. 2024 Jan;264:113740. doi: 10.1016/j.jpeds.2023.113740. Epub 2023 Sep 16. J Pediatr. 2024. PMID: 37717908 Clinical Trial.
OBJECTIVE: To test whether a neonatal intensive care unit-based language curriculum for families with preterm infants enhances the language environment and postdischarge Bayley Scales of Infant and Toddler Development (BSID)-III language …
OBJECTIVE: To test whether a neonatal intensive care unit-based language curriculum for families with preterm
Antibiotic Prophylaxis in Infants with Grade III, IV, or V Vesicoureteral Reflux.
Morello W, Baskin E, Jankauskiene A, Yalcinkaya F, Zurowska A, Puccio G, Serafinelli J, La Manna A, Krzemień G, Pennesi M, La Scola C, Becherucci F, Brugnara M, Yuksel S, Mekahli D, Chimenz R, De Palma D, Zucchetta P, Vajauskas D, Drozdz D, Szczepanska M, Caliskan S, Lombet J, Minoli DG, Guarino S, Gulleroglu K, Ruzgiene D, Szmigielska A, Barbi E, Ozcakar ZB, Kranz A, Pasini A, Materassi M, De Rechter S, Ariceta G, Weber LT, Marzuillo P, Alberici I, Taranta-Janusz K, Caldas Afonso A, Tkaczyk M, Català M, Cabrera Sevilla JE, Mehls O, Schaefer F, Montini G; PREDICT Study Group. Morello W, et al. N Engl J Med. 2023 Sep 14;389(11):987-997. doi: 10.1056/NEJMoa2300161. Epub 2023 Sep 12. N Engl J Med. 2023. PMID: 37702442 Free article. Clinical Trial.
BACKGROUND: The efficacy of continuous antibiotic prophylaxis in preventing urinary tract infection (UTI) in infants with grade III, IV, or V vesicoureteral reflux is controversial. METHODS: In this investigator-initiated, randomized, open-label trial performed in 39 Europ …
BACKGROUND: The efficacy of continuous antibiotic prophylaxis in preventing urinary tract infection (UTI) in infants with grade III, …
Two-Year Outcomes After Minimally Invasive Surfactant Therapy in Preterm Infants: Follow-Up of the OPTIMIST-A Randomized Clinical Trial.
Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Özkan H, Hulzebos CV, Schmölzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Goss KCW, Tauscher MK, Murthy V, Ali SKM, Clark HW, Soll RF, Johnson S, Cheong JLY, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Dargaville PA, et al. JAMA. 2023 Sep 19;330(11):1054-1063. doi: 10.1001/jama.2023.15694. JAMA. 2023. PMID: 37695601 Free PMC article. Clinical Trial.
IMPORTANCE: The long-term effects of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome remain to be definitively clarified. ...DESIGN, SETTING, AND PARTICIPANTS: Follow- …
IMPORTANCE: The long-term effects of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in pret
Timing of Primary Surgery for Cleft Palate.
Gamble C, Persson C, Willadsen E, Albery L, Soegaard Andersen H, Zattoni Antoneli M, Appelqvist M, Aukner R, Bodling P, Bowden M, Brunnegård K, Cairns G, Calladine S, Campbell L, Clayton-Smith J, Cooper R, Conroy E, El-Angbawi A, Kildegaard Emborg B, Enfält Wikman J, Fitzpatrick B, Fukushiro AP, Guedes de Azevedo Bento Gonçalves C, Havstam C, Hvistendahl AK, Jorgensen LD, Klinto K, Berntsen Kvinnsland M, Larham C, Lemvik J, Leturgie L, Liljerehn E, Lodge N, Lohmander A, McMahon S, Mehendale F, Miguel HC, Moe M, Nielsen JB, Nyberg J, Pedersen NH, Phippen G, Alvarez Piazentin-Penna SH, Patrick K, Pliskin L, Rigby L, Semb G, Southby L, Sporre M, Björkman Taleman AS, Tangstad J, Trindade IEK, Underwood I, van Eeden S, Westberg LR, Williamson PR, Paciello Yamashita R, Munro K, Walsh T, Shaw W; TOPS Study Group. Gamble C, et al. N Engl J Med. 2023 Aug 31;389(9):795-807. doi: 10.1056/NEJMoa2215162. N Engl J Med. 2023. PMID: 37646677 Free PMC article. Clinical Trial.
Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth. RESULTS: We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infa
Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth. RESUL …
Apnoea-triggered increase in fraction of inspired oxygen in preterm infants: a randomised cross-over study.
Marshall A, Ladlow OJ, Bannink C, Lim K, Ali SKM, Gale TJ, Dargaville PA. Marshall A, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Dec 15;109(1):81-86. doi: 10.1136/archdischild-2023-325849. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 37640527 Clinical Trial.
OBJECTIVES: To investigate the impact of a pre-emptive apnoea triggered oxygen response on oxygen saturation (SpO(2)) targeting following central apnoea in preterm infants. DESIGN: Interventional crossover study of a 12-hour period of automated oxygen control with a …
OBJECTIVES: To investigate the impact of a pre-emptive apnoea triggered oxygen response on oxygen saturation (SpO(2)) targeting following ce …
Early Human Milk Fortification in Infants Born Extremely Preterm: A Randomized Trial.
Salas AA, Gunawan E, Nguyen K, Reeves A, Argent V, Finck A, Carlo WA. Salas AA, et al. Pediatrics. 2023 Sep 1;152(3):e2023061603. doi: 10.1542/peds.2023-061603. Pediatrics. 2023. PMID: 37551512 Clinical Trial.
OBJECTIVES: Enteral nutrition with unfortified human milk during the first 2 postnatal weeks often leads to cumulative protein and energy deficits among preterm infants. Fortified human milk administered soon after birth could increase fat-free mass (FFM) and improv …
OBJECTIVES: Enteral nutrition with unfortified human milk during the first 2 postnatal weeks often leads to cumulative protein and energy de …
A Social Care System Implemented in Pediatric Primary Care: A Cluster RCT.
Garg A, Brochier A, Tripodis Y, Messmer E, Drainoni ML. Garg A, et al. Pediatrics. 2023 Aug 1;152(2):e2023061513. doi: 10.1542/peds.2023-061513. Pediatrics. 2023. PMID: 37492934 Clinical Trial.
OBJECTIVES: To assess the implementation and effectiveness of the augmented WE CARE social care system on low-income children's health care utilization and child maltreatment outcomes. ...RESULTS: Overall, 878 children were followed until age 3. Implementatio …
OBJECTIVES: To assess the implementation and effectiveness of the augmented WE CARE social care system on low-income children' …
Randomised control trial of oxygen assist module in preterm infants on high-flow nasal cannula support.
Nair V, Kannan Loganathan P, Lal MK, Bachman TE, Fantl R. Nair V, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Dec 15;109(1):65-69. doi: 10.1136/archdischild-2023-325661. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 37451840 Clinical Trial.
OBJECTIVE: To evaluate the efficacy of automatic oxygen control (A-FiO(2)) in reducing the extremes of oxygen saturations (SpO(2)<80% and SpO(2)>98%) in preterm infants on high-flow nasal cannula (HFNC) respiratory support using Vapotherm Precision Flow. DESIG …
OBJECTIVE: To evaluate the efficacy of automatic oxygen control (A-FiO(2)) in reducing the extremes of oxygen saturations (SpO(2)<80% and …
Mask ventilation using volume-targeted neonatal ventilator for neonatal resuscitation: a randomised cross-over simulation study.
Law BHY, Madani Kia T, Trinh F, Schmölzer GM. Law BHY, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Dec 15;109(1):46-51. doi: 10.1136/archdischild-2023-325320. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 37369598 Clinical Trial.
DESIGN: Prospective randomised cross-over simulation study. Participants were briefly trained to use a neonatal ventilator for mask ventilation. Each participant was fitted with eye-tracking glasses to record visual attention (VA) and performed two simulated preterm
DESIGN: Prospective randomised cross-over simulation study. Participants were briefly trained to use a neonatal ventilator for mask v …
Just-In-Time Neonatal Endotracheal Intubation Simulation Training: A Randomized Controlled Trial.
Gizicki E, Assaad MA, Massé É, Bélanger S, Olivier F, Moussa A. Gizicki E, et al. J Pediatr. 2023 Oct;261:113576. doi: 10.1016/j.jpeds.2023.113576. Epub 2023 Jun 21. J Pediatr. 2023. PMID: 37353151 Clinical Trial.
OBJECTIVE: To assess if simulation-based just-in-time training (JITT, short video and simulation) is superior to video training (5-minute video) in acquiring skill in neonatal endotracheal intubation (ETI). STUDY DESIGN: A Canadian multicenter randomized trial recruited ju …
OBJECTIVE: To assess if simulation-based just-in-time training (JITT, short video and simulation) is superior to video training (5-minute vi …
Ultrasonographic Estimation of Ventricular Volume in Infants Born Preterm with Posthemorrhagic Ventricular Dilatation: A Nested Substudy of the Randomized Controlled Early Versus Late Ventricular Intervention Study (ELVIS) Trial.
Benavente-Fernández I, Steggerda SJ, Liem KD, Lubián-López S, de Vries LS. Benavente-Fernández I, et al. J Pediatr. 2023 Oct;261:113578. doi: 10.1016/j.jpeds.2023.113578. Epub 2023 Jun 22. J Pediatr. 2023. PMID: 37353143 Free article. Clinical Trial.
OBJECTIVE: To study the potential role of ventricular volume (VV) estimation in the management of posthemorrhagic ventricular dilatation related to the need for ventriculoperitoneal (VP)-shunt insertion and 2-year neurodevelopmental outcome in infants born preterm. …
OBJECTIVE: To study the potential role of ventricular volume (VV) estimation in the management of posthemorrhagic ventricular dilatation rel …
Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study.
Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Banniettis N, et al. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542/peds.2022-060428. Pediatrics. 2023. PMID: 37309607 Clinical Trial.
This large phase 3 study evaluated safety and tolerability of V114 in infants. METHODS: In total, 2409 infants were randomized to receive V114 or PCV13 at 2, 4, 6, and 12 to 15 months of age. ...CONCLUSIONS: V114 is well tolerated and has a generally comparable safe …
This large phase 3 study evaluated safety and tolerability of V114 in infants. METHODS: In total, 2409 infants were randomized …
Does Growth Velocity Affect Associations between Birth Weight and Neurodevelopment for Infants Born Very Preterm?
Sériès T, Guillot M, Angoa G, Pronovost E, Ndiaye ABKT, Mohamed I, Simonyan D, Lavoie PM, Synnes A, Marc I; MOBYDIck trial group. Sériès T, et al. J Pediatr. 2023 Sep;260:113531. doi: 10.1016/j.jpeds.2023.113531. Epub 2023 Jun 1. J Pediatr. 2023. PMID: 37268036 Clinical Trial.
OBJECTIVE: To determine how neonatal growth velocity affects the association between birth weight and neurodevelopmental outcomes in infants born preterm. STUDY DESIGN: This study is a secondary analysis of the Maternal Omega-3 Supplementation to Reduce Bronc …
OBJECTIVE: To determine how neonatal growth velocity affects the association between birth weight and neurodevelopmental outcomes in …
Securement of Umbilical Venous Catheter Using Cyanoacrylate Glue: A Randomized Controlled Trial.
D'Andrea V, Prontera G, Pinna G, Cota F, Fattore S, Costa S, Migliorato M, Barone G, Pittiruti M, Vento G. D'Andrea V, et al. J Pediatr. 2023 Sep;260:113517. doi: 10.1016/j.jpeds.2023.113517. Epub 2023 May 26. J Pediatr. 2023. PMID: 37244573 Free article. Clinical Trial.
STUDY DESIGN: This was a single-center, randomized, controlled, nonblinded trial. All infants requiring an UVC according to our local policy were included in the study. Infants with a UVC with a centrally located tip as verified by real-time ultrasound examination w …
STUDY DESIGN: This was a single-center, randomized, controlled, nonblinded trial. All infants requiring an UVC according to our local …
Improved Neurodevelopmental Outcomes at 5.5 Years of Age in Children Who Received Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula Through 12 Months: A Randomized Controlled Trial.
Colombo J, Harris CL, Wampler JL, Zhuang W, Shaddy DJ, Liu BY, Wu SS. Colombo J, et al. J Pediatr. 2023 Oct;261:113483. doi: 10.1016/j.jpeds.2023.113483. Epub 2023 May 14. J Pediatr. 2023. PMID: 37192722 Free article. Clinical Trial.
OBJECTIVE: To evaluate the neurodevelopmental outcomes at 5.5 years of age in children who were previously randomized to cow milk-based infant formula (control) or similar formula (milk fat globule membrane + lactoferrin) with added sources of bovine milk fat globule membr …
OBJECTIVE: To evaluate the neurodevelopmental outcomes at 5.5 years of age in children who were previously randomized to cow milk-based i
Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy.
Greenhawt M, Sindher SB, Wang J, O'Sullivan M, du Toit G, Kim EH, Albright D, Anvari S, Arends N, Arkwright PD, Bégin P, Blumchen K, Bourrier T, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris SL, Dorsey MJ, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, Giovannini-Chami L, Hourihane JO, Jay N, Jones SM, Kerns LA, Kloepfer KM, Leonard S, Lezmi G, Lieberman JA, Lomas J, Makhija M, Parrish C, Peake J, Perrett KP, Petroni D, Pfützner W, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma HP, Trujillo J, Turner PJ, Tuttle K, Upton JE, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wood RA, Bee KJ, Campbell DE, Green TD, Rouissi R, Peillon A, Bahnson HT, Bois T, Sampson HA, Burks AW. Greenhawt M, et al. N Engl J Med. 2023 May 11;388(19):1755-1766. doi: 10.1056/NEJMoa2212895. N Engl J Med. 2023. PMID: 37163622 Clinical Trial.
An Integrated Mother-Child Intervention on Child Development and Maternal Mental Health.
Tofail F, Islam M, Akter F, Zonji S, Roy B, Hossain SJ, Horaira A, Akter S, Goswami D, Brooks A, Hamadani J. Tofail F, et al. Pediatrics. 2023 May 1;151(Suppl 2):e2023060221G. doi: 10.1542/peds.2023-060221G. Pediatrics. 2023. PMID: 37125887 Clinical Trial.
OBJECTIVES: To evaluate an integrated, low-cost, facility-based group intervention designed to promote child care, boost maternal mental-wellbeing, reduce harsh discipline, and improve children's health, nutrition, and early development. ...Maternal outcomes were depressiv …
OBJECTIVES: To evaluate an integrated, low-cost, facility-based group intervention designed to promote child care, boost maternal men …
Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.
Young LW, Ounpraseuth ST, Merhar SL, Hu Z, Simon AE, Bremer AA, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Poindexter BB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Telang S, Fung CM, Wright T, Reynolds AM, Hahn DW, Ross J, McAllister JM, Crowley M, Shaikh SK, Puopolo KM, Christ L, Brown J, Riccio J, Wong Ramsey K, Akshatha, Braswell EF, Tucker L, McAlmon KR, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Devlin LA; ACT NOW Collaborative. Young LW, et al. N Engl J Med. 2023 Jun 22;388(25):2326-2337. doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30. N Engl J Med. 2023. PMID: 37125831 Free PMC article. Clinical Trial.
BACKGROUND: Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. ...The …
BACKGROUND: Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of ne
Community Health Workers in Early Childhood Well-Child Care for Medicaid-Insured Children: A Randomized Clinical Trial.
Coker TR, Liljenquist K, Lowry SJ, Fiscella K, Weaver MR, Ortiz J, LaFontaine R, Silva J, Salaguinto T, Johnson G, Friesema L, Porras-Javier L, Guerra LJS, Szilagyi PG. Coker TR, et al. JAMA. 2023 May 23;329(20):1757-1767. doi: 10.1001/jama.2023.7197. JAMA. 2023. PMID: 37120800 Free PMC article. Clinical Trial.
IMPORTANCE: An intervention model (the Parent-focused Redesign for Encounters, Newborns to Toddlers; the PARENT intervention) for well-child care that integrates a community health worker into preventive care services may enhance early childhood well-child …
IMPORTANCE: An intervention model (the Parent-focused Redesign for Encounters, Newborns to Toddlers; the PARENT intervention) for wel …
National priority setting partnership using a Delphi consensus process to develop neonatal research questions suitable for practice-changing randomised trials in the UK.
Evans K, Battersby C, Boardman JP, Boyle E, Carroll W, Dinwiddy K, Dorling J, Gallagher K, Hardy P, Johnston E, Mactier H, Marcroft C, Webbe JWH, Gale C. Evans K, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):569-574. doi: 10.1136/archdischild-2023-325504. Epub 2023 Apr 24. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 37094919 Free PMC article. Clinical Trial.
BACKGROUND: The provision of neonatal care is variable and commonly lacks adequate evidence base; strategic development of methodologically robust clinical trials is needed to improve outcomes and maximise research resources. ...CONCLUSIONS: We have identified and p …
BACKGROUND: The provision of neonatal care is variable and commonly lacks adequate evidence base; strategic development of met …
Cerebral Oximetry Monitoring in Extremely Preterm Infants.
Hansen ML, Pellicer A, Hyttel-Sørensen S, Ergenekon E, Szczapa T, Hagmann C, Naulaers G, Mintzer J, Fumagalli M, Dimitriou G, Dempsey E, Tkaczyk J, Cheng G, Fredly S, Heuchan AM, Pichler G, Fuchs H, Nesargi S, Hahn GH, Piris-Borregas S, Širc J, Alsina-Casanova M, Stocker M, Ozkan H, Sarafidis K, Hopper AO, Karen T, Rzepecka-Weglarz B, Oguz SS, Arruza L, Memisoglu AC, Del Rio Florentino R, Baserga M, Maton P, Truttmann AC, de Las Cuevas I, Agergaard P, Zafra P, Bender L, Lauterbach R, Lecart C, de Buyst J, El-Khuffash A, Curley A, Vaccarello OO, Miletin J, Papathoma E, Vesoulis Z, Vento G, Cornette L, Lopez LS, Yasa B, Klamer A, Agosti M, Baud O, Mastretta E, Cetinkaya M, McCall K, Zeng S, Hatzidaki E, Bargiel A, Marciniak S, Gao X, Huijia L, Chalak L, Yang L, Rao SA, Xu X, Gonzalez BL, Wilinska M, Yin Z, Sadowska-Krawczenko I, Serrano-Viñuales I, Krolak-Olejnik B, Ybarra MM, Morales-Betancourt C, Korček P, Teresa-Palacio M, Mosca F, Hergenhan A, Koksal N, Tsoni K, Kadri MM, Knöpfli C, Rafinska-Wazny E, Akin MS, Nordvik T, Peng Z, Kersin SG, Thewissen L, Alarcon A, Healy D, Urlesberger B, Baş M, Baumgartner J, Skylogianni E, Karadyova V, Valverde E, Bergon-Sendin E, Kucera J, Pison… See abstract for full author list ➔ Hansen ML, et al. N Engl J Med. 2023 Apr 20;388(16):1501-1511. doi: 10.1056/NEJMoa2207554. N Engl J Med. 2023. PMID: 37075142 Clinical Trial.
BACKGROUND: The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. METHODS: In this randomized, phase 3 trial conducted at 70 sites in 17 countries, …
BACKGROUND: The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, ev …
Dersimelagon in Erythropoietic Protoporphyrias.
Balwani M, Bonkovsky HL, Levy C, Anderson KE, Bissell DM, Parker C, Takahashi F, Desnick RJ, Belongie K; Endeavor Investigators. Balwani M, et al. N Engl J Med. 2023 Apr 13;388(15):1376-1385. doi: 10.1056/NEJMoa2208754. N Engl J Med. 2023. PMID: 37043653 Clinical Trial.
Real-Time Intubation and Ventilation Feedback: A Randomized Controlled Simulation Study.
Dvorsky R, Rings F, Bibl K, Roessler L, Kumer L, Steinbauer P, Schwarz H, Ritschl V, Schmölzer GM, Berger A, Werther T, Wagner M. Dvorsky R, et al. Pediatrics. 2023 May 1;151(5):e2022059839. doi: 10.1542/peds.2022-059839. Pediatrics. 2023. PMID: 37038898 Clinical Trial.
Participants had to execute ventilation and intubation maneuvers on a newborn manikin. Participants were randomized into 3 groups. In group A (no-access), the feedback devices were not visible but recording. ...
Participants had to execute ventilation and intubation maneuvers on a newborn manikin. Participants were randomized into 3 groups. In …
Safety of High Dose Erythropoietin Used with Therapeutic Hypothermia as Treatment for Newborn Hypoxic-Ischemic Encephalopathy: Secondary Analysis of the HEAL Randomized Controlled Trial.
Juul SE, Comstock BA, Cornet MC, Gonzalez FF, Mayock DE, Glass HC, Schreiber MD, Heagerty PJ, Wu YW. Juul SE, et al. J Pediatr. 2023 Jul;258:113400. doi: 10.1016/j.jpeds.2023.113400. Epub 2023 Apr 4. J Pediatr. 2023. PMID: 37019334 Free PMC article. Clinical Trial.
OBJECTIVE: To assess whether high dose erythropoietin (Epo) treatment of cooled infants with neonatal hypoxic ischemic encephalopathy results in a higher risk of prespecified serious adverse events (SAEs). STUDY DESIGN: Five hundred infants born at 36 weeks o …
OBJECTIVE: To assess whether high dose erythropoietin (Epo) treatment of cooled infants with neonatal hypoxic ischemic encepha …
Platelet Transfusions in a Multi-Neonatal Intensive Care Unit Health Care Organization Before and After Publication of the PlaNeT-2 Clinical Trial.
Bahr TM, Christensen TR, Henry E, Astin M, Ilstrup SJ, Ohls RK, Christensen RD. Bahr TM, et al. J Pediatr. 2023 Jun;257:113388. doi: 10.1016/j.jpeds.2023.03.003. Epub 2023 Mar 16. J Pediatr. 2023. PMID: 36933765 Clinical Trial.
OBJECTIVES: To evaluate whether implementing more restrictive neonatal intensive care unit (NICU) platelet transfusion guidelines following the Platelets for Neonatal Transfusion - Study 2 randomized controlled trial (transfusion threshold chang …
OBJECTIVES: To evaluate whether implementing more restrictive neonatal intensive care unit (NICU) platelet trans …
Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis.
Silverberg JI, Guttman-Yassky E, Thaçi D, Irvine AD, Stein Gold L, Blauvelt A, Simpson EL, Chu CY, Liu Z, Gontijo Lima R, Pillai SG, Seneschal J; ADvocate1 and ADvocate2 Investigators. Silverberg JI, et al. N Engl J Med. 2023 Mar 23;388(12):1080-1091. doi: 10.1056/NEJMoa2206714. Epub 2023 Mar 15. N Engl J Med. 2023. PMID: 36920778 Clinical Trial.
Late permissive hypercapnia and respiratory stability among very preterm infants: a pilot randomised trial.
Travers CP, Carlo WA, Nakhmani A, Laney D, Chahine RA, Aban I, Ambalavanan N. Travers CP, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Sep;108(5):530-534. doi: 10.1136/archdischild-2022-325166. Epub 2023 Mar 13. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 36914233 Free PMC article. Clinical Trial.
OBJECTIVE: Determine if targeting higher transcutaneous carbon dioxide improves respiratory stability among very preterm infants on ventilatory support. DESIGN: Single-centre pilot randomised clinical trial. SETTING: The University of Alabama at Birmingham. PATIENTS …
OBJECTIVE: Determine if targeting higher transcutaneous carbon dioxide improves respiratory stability among very preterm infants
Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age.
Muñoz FM, Sher LD, Sabharwal C, Gurtman A, Xu X, Kitchin N, Lockhart S, Riesenberg R, Sexter JM, Czajka H, Paulsen GC, Maldonado Y, Walter EB, Talaat KR, Englund JA, Sarwar UN, Hansen C, Iwamoto M, Webber C, Cunliffe L, Ukkonen B, Martínez SN, Pahud BA, Munjal I, Domachowske JB, Swanson KA, Ma H, Koury K, Mather S, Lu C, Zou J, Xie X, Shi PY, Cooper D, Türeci Ö, Şahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Muñoz FM, et al. N Engl J Med. 2023 Feb 16;388(7):621-634. doi: 10.1056/NEJMoa2211031. N Engl J Med. 2023. PMID: 36791162 Free PMC article. Clinical Trial.
Clinic-Based Financial Coaching and Missed Pediatric Preventive Care: A Randomized Trial.
Schickedanz A, Perales L, Holguin M, Rhone-Collins M, Robinson H, Tehrani N, Smith L, Chung PJ, Szilagyi PG. Schickedanz A, et al. Pediatrics. 2023 Mar 1;151(3):e2021054970. doi: 10.1542/peds.2021-054970. Pediatrics. 2023. PMID: 36727274 Free PMC article. Clinical Trial.
METHODS: In this community-partnered randomized controlled trial comparing clinic-based financial coaching to usual care among low-income parent-infant dyads attending pediatric preventive care visits, we examined the impact of the longitudinal financial inte …
METHODS: In this community-partnered randomized controlled trial comparing clinic-based financial coaching to usual care among low-in …
Effect of Early High-Flow Nasal Oxygen vs Standard Oxygen Therapy on Length of Hospital Stay in Hospitalized Children With Acute Hypoxemic Respiratory Failure: The PARIS-2 Randomized Clinical Trial.
Franklin D, Babl FE, George S, Oakley E, Borland ML, Neutze J, Acworth J, Craig S, Jones M, Gannon B, Shellshear D, McCay H, Wallace A, Hoeppner T, Wildman M, Mattes J, Pham TMT, Miller L, Williams A, O'Brien S, Lawrence S, Bonisch M, Gibbons K, Moloney S, Waugh J, Hobbins S, Grew S, Fahy R, Dalziel SR, Schibler A. Franklin D, et al. JAMA. 2023 Jan 17;329(3):224-234. doi: 10.1001/jama.2022.21805. JAMA. 2023. PMID: 36648469 Free PMC article. Clinical Trial.
IMPORTANCE: Nasal high-flow oxygen therapy in infants with bronchiolitis and hypoxia has been shown to reduce the requirement to escalate care. ...There were 9 secondary outcomes, including length of oxygen therapy and admission to the intensive care u …
IMPORTANCE: Nasal high-flow oxygen therapy in infants with bronchiolitis and hypoxia has been shown to reduce the requirement to esca …
Low dose or very low dose phenylephrine and cyclopentolate microdrops for retinopathy of prematurity eye examinations (The Little Eye Drop Study): a randomised controlled non-inferiority trial.
Kremer LJ, Medlicott N, Sime MJ, Broadbent R, Edmonds L, Berry MJ, Austin NC, Alsweiler JM, Reith DM. Kremer LJ, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Jul;108(4):380-386. doi: 10.1136/archdischild-2022-324929. Epub 2023 Jan 2. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 36593111 Free PMC article. Clinical Trial.
DESIGN: Multicentre, prospective, randomised controlled, non-inferiority clinical trial. SETTING: Four neonatal intensive care units in Aotearoa, New Zealand from October 2019 to September 2021. ...CONCLUSION: VLD microdrops enable safe and effective s …
DESIGN: Multicentre, prospective, randomised controlled, non-inferiority clinical trial. SETTING: Four neonatal intensive c
Effect of systemic hydrocortisone in ventilated preterm infants on parent-reported behavioural outcomes at 2 years' corrected age: follow-up of a randomised clinical trial.
Halbmeijer NM, Onland W, Cools F, Swarte RM, van der Heide-Jalving M, Dijk P, Mulder-de Tollenaer S, Tan RNGB, Mohns T, Bruneel E, van Heijst AFJ, Kramer B, Debeer A, van Weissenbruch MM, Marechal Y, Blom H, Plaskie K, Offringa M, van Wassenaer-Leemhuis AG, van Kaam AH, Aarnoudse-Moens CSH; SToP-BPD study group. Halbmeijer NM, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Jul;108(4):373-379. doi: 10.1136/archdischild-2022-324179. Epub 2023 Jan 2. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 36593110 Clinical Trial.
OBJECTIVE: To report the parent-reported behavioural outcomes of infants included in the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants study at 2 years' corrected age (CA). DESIGN: Randomised placebo-controlled trial. SETTIN …
OBJECTIVE: To report the parent-reported behavioural outcomes of infants included in the Systemic Hydrocortisone To Prevent Bronchopu …
A Randomized Trial of an Exclusive Human Milk Diet in Neonates with Single Ventricle Physiology.
Blanco CL, Hair A, Justice LB, Roddy D, Bonagurio K, Williams PK, Machado D, Marino BS, Chi A, Takao C, Gordon EE, Ashrafi A, Cacho N, Pruetz JD, Costello JM, Cooper DS; Cardiac Neonate Nutrition Study Group. Blanco CL, et al. J Pediatr. 2023 May;256:105-112.e4. doi: 10.1016/j.jpeds.2022.11.043. Epub 2022 Dec 14. J Pediatr. 2023. PMID: 36528055 Clinical Trial.
During the 30 days after feeds were started postoperatively, infants in the intervention group received human milk fortified once enteral intake reached 60 mL/kg/day with a human milk-based fortifier designed for term neonates. ...Perioperative feeding and parentera …
During the 30 days after feeds were started postoperatively, infants in the intervention group received human milk fortified once ent …
Predictors of Intensive Care Admission in Hypoxemic Bronchiolitis Infants, Secondary Analysis of a Randomized Trial.
Franklin D, Babl FE, Neutze J, Craig S, Oakley E, Furyk J, Frampton CM, Hasan N, Pham TM, Miller L, Fraser JF, Dalziel SR, Schibler A; A Pediatric Acute Respiratory Intervention Study (PARIS) on behalf of PREDICT. Franklin D, et al. J Pediatr. 2023 May;256:92-97.e1. doi: 10.1016/j.jpeds.2022.12.006. Epub 2022 Dec 14. J Pediatr. 2023. PMID: 36528052 Clinical Trial.
OBJECTIVES: To evaluate in a preplanned secondary analysis of our parent randomized controlled trial predictors of intensive care unit (ICU) admission in infants with bronchiolitis and analyze if these predictors are equally robust for children receiving high …
OBJECTIVES: To evaluate in a preplanned secondary analysis of our parent randomized controlled trial predictors of intensive care
Evaluation of the safety, immunogenicity, and faecal shedding of novel oral polio vaccine type 2 in healthy newborn infants in Bangladesh: a randomised, controlled, phase 2 clinical trial.
Zaman K, Bandyopadhyay AS, Hoque M, Gast C, Yunus M, Jamil KM, Mainou BA, Konopka-Anstadt JL, Hendley WS, Vincent A, Clemens R, Clemens SAC, Ross AG, Clemens JD, Tritama E. Zaman K, et al. Lancet. 2023 Jan 14;401(10371):131-139. doi: 10.1016/S0140-6736(22)02397-2. Epub 2022 Dec 7. Lancet. 2023. PMID: 36495882 Free PMC article. Clinical Trial.
We aimed to assess these aspects of nOPV2 in poliovirus vaccine-naive newborn infants. METHODS: In this randomised, double-blind, controlled, phase 2 trial we enrolled newborn infants at the Matlab Health Research Centre, Chandpur, Bangladesh. ...INTER …
We aimed to assess these aspects of nOPV2 in poliovirus vaccine-naive newborn infants. METHODS: In this randomised, double-bli …
Promoting Cognitive Stimulation in Parents Across Infancy and Toddlerhood: A Randomized Clinical Trial.
Miller EB, Roby E, Zhang Y, Coskun L, Rosas JM, Scott MA, Gutierrez J, Shaw DS, Mendelsohn AL, Morris-Perez PA. Miller EB, et al. J Pediatr. 2023 Apr;255:159-165.e4. doi: 10.1016/j.jpeds.2022.11.013. Epub 2022 Dec 5. J Pediatr. 2023. PMID: 36481243 Free PMC article. Clinical Trial.
STUDY DESIGN: This was a single-blind, 2-site randomized clinical trial of the Smart Beginnings intervention. Enrollment took place at birth in postpartum units of hospitals in New York City and Pittsburgh, Pennsylvania, with a consecutive sample of 403 mother-infant
STUDY DESIGN: This was a single-blind, 2-site randomized clinical trial of the Smart Beginnings intervention. Enrollment took place at birth …
Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus.
Hundscheid T, Onland W, Kooi EMW, Vijlbrief DC, de Vries WB, Dijkman KP, van Kaam AH, Villamor E, Kroon AA, Visser R, Mulder-de Tollenaer SM, De Bisschop B, Dijk PH, Avino D, Hocq C, Zecic A, Meeus M, de Baat T, Derriks F, Henriksen TB, Kyng KJ, Donders R, Nuytemans DHGM, Van Overmeire B, Mulder AL, de Boode WP; BeNeDuctus Trial Investigators. Hundscheid T, et al. N Engl J Med. 2023 Mar 16;388(11):980-990. doi: 10.1056/NEJMoa2207418. Epub 2022 Dec 6. N Engl J Med. 2023. PMID: 36477458 Clinical Trial.
BACKGROUND: Cyclooxygenase inhibitors are commonly used in infants with patent ductus arteriosus (PDA), but the benefit of these drugs is uncertain. METHODS: In this multicenter, noninferiority trial, we randomly assigned infants with echocardiographically confirmed …
BACKGROUND: Cyclooxygenase inhibitors are commonly used in infants with patent ductus arteriosus (PDA), but the benefit of these drug …
Prophylactic surfactant nebulisation for the early aeration of the preterm lung: a randomised clinical trial.
Gaertner VD, Minocchieri S, Waldmann AD, Mühlbacher T, Bassler D, Rüegger CM; SUNSET study group. Gaertner VD, et al. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):217-223. doi: 10.1136/archdischild-2022-324519. Epub 2022 Nov 24. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 36424125 Clinical Trial.
DESIGN: Parallel, randomised clinical trial, conducted between March 2021 and January 2022. SETTING: Delivery room (DR) of a tertiary neonatal centre in Zurich, Switzerland. PATIENTS: Preterm infants between 26 (0/7) and 31 (6/7) weeks gestation INTERVENTIONS …
DESIGN: Parallel, randomised clinical trial, conducted between March 2021 and January 2022. SETTING: Delivery room (DR) of a tertiary neo
Mechanisms affecting the gut of preterm infants in enteral feeding trials: a nested cohort within a randomised controlled trial of lactoferrin.
Young G, Berrington JE, Cummings S, Dorling J, Ewer AK, Frau A, Lett L, Probert C, Juszczak E, Kirby J, Beck LC, Renwick VL, Lamb C, Lanyon CV, McGuire W, Stewart C, Embleton N. Young G, et al. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):272-279. doi: 10.1136/archdischild-2022-324477. Epub 2022 Nov 17. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 36396443 Free PMC article. Clinical Trial.
OBJECTIVE: To determine the impact of supplemental bovine lactoferrin on the gut microbiome and metabolome of preterm infants. DESIGN: Cohort study nested within a randomised controlled trial (RCT). ...RESULTS: 10 990 stool and 22 341 urine samples were collected. A …
OBJECTIVE: To determine the impact of supplemental bovine lactoferrin on the gut microbiome and metabolome of preterm infants. …
Three Different Regimens for Vitamin K Birth Prophylaxis in Infants Born Preterm: A Randomized Clinical Trial.
Hunnali CR, Devi U, Kitchanan S, Sethuraman G. Hunnali CR, et al. J Pediatr. 2023 Apr;255:98-104. doi: 10.1016/j.jpeds.2022.10.031. Epub 2022 Nov 4. J Pediatr. 2023. PMID: 36343740 Clinical Trial.
OBJECTIVE: To study the efficacy of 3 different vitamin K birth prophylaxis regimens in infants born premature. STUDY DESIGN: This was an open-label, parallel-group, randomized clinical trial conducted in a tertiary neonatal care unit in India. Infants
OBJECTIVE: To study the efficacy of 3 different vitamin K birth prophylaxis regimens in infants born premature. STUDY DESIGN: This wa …
Early Amino Acids in Extremely Preterm Infants and Neurodisability at 2 Years.
Bloomfield FH, Jiang Y, Harding JE, Crowther CA, Cormack BE; ProVIDe Trial Group. Bloomfield FH, et al. N Engl J Med. 2022 Nov 3;387(18):1661-1672. doi: 10.1056/NEJMoa2204886. N Engl J Med. 2022. PMID: 36322845 Clinical Trial.
BACKGROUND: Whether higher parenteral amino acid intake improves outcomes in infants with extremely low birth weight is unclear. METHODS: In this multicenter, parallel-group, double-blind, randomized, placebo-controlled trial, we assigned infants with birth weights …
BACKGROUND: Whether higher parenteral amino acid intake improves outcomes in infants with extremely low birth weight is unclear. METH …
Nasal high-flow therapy to Optimise Stability during Intubation: the NOSI pilot trial.
Foran J, Moore CM, Ni Chathasaigh CM, Moore S, Purna JR, Curley A. Foran J, et al. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):244-249. doi: 10.1136/archdischild-2022-324649. Epub 2022 Oct 28. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 36307187 Free PMC article. Clinical Trial.
DESIGN AND SETTING: This double-blinded randomised controlled pilot trial was conducted at a single, tertiary neonatal centre from October 2020 to October 2021. PARTICIPANTS: Infants undergoing oral intubation in neonatal intensive care were inc …
DESIGN AND SETTING: This double-blinded randomised controlled pilot trial was conducted at a single, tertiary neonatal centre from Oc …
Do newborn infants exhale through the CPAP system? Secondary analysis of a randomised cross-over trial.
Gunnarsdottir K, Falk M, Baldursdottir S, Donaldsson S, Jonsson B, Drevhammar T. Gunnarsdottir K, et al. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):232-236. doi: 10.1136/archdischild-2022-324462. Epub 2022 Oct 19. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 36261145 Free PMC article. Clinical Trial.
BACKGROUND: During nasal continuous positive airway pressure (nCPAP) treatment in neonates, leakage is inevitable and can lead to reduced distending pressure in the lungs of the infant. ...We retrospectively examined respiratory curves for the 50 infants incl …
BACKGROUND: During nasal continuous positive airway pressure (nCPAP) treatment in neonates, leakage is inevitable and can lead to red …
Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.
Anderson EJ, Creech CB, Berthaud V, Piramzadian A, Johnson KA, Zervos M, Garner F, Griffin C, Palanpurwala K, Turner M, Gerber J, Bennett RL, Ali K, Ampajwala M, Berman G, Nayak J, Chronis C, Rizzardi B, Muller WJ, Smith CA, Fuchs G, Hsia D, Tomassini JE, DeLucia D, Reuter C, Kuter B, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Aunins A, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Anderson EJ, et al. N Engl J Med. 2022 Nov 3;387(18):1673-1687. doi: 10.1056/NEJMoa2209367. Epub 2022 Oct 19. N Engl J Med. 2022. PMID: 36260859 Free PMC article. Clinical Trial.
Randomized Trial of Surfactant Therapy via Laryngeal Mask Airway Versus Brief Tracheal Intubation in Neonates Born Preterm.
Gallup JA, Ndakor SM, Pezzano C, Pinheiro JMB. Gallup JA, et al. J Pediatr. 2023 Mar;254:17-24.e2. doi: 10.1016/j.jpeds.2022.10.009. Epub 2022 Oct 12. J Pediatr. 2023. PMID: 36241051 Clinical Trial.
OBJECTIVE: To evaluate the possible noninferiority of surfactant administration via laryngeal mask airway (LMA) vs endotracheal tube (ETT) in avoiding the requirement for mechanical ventilation in preterm neonates with respiratory distress syndrome (RDS). STUDY DESI …
OBJECTIVE: To evaluate the possible noninferiority of surfactant administration via laryngeal mask airway (LMA) vs endotracheal tube (ETT) i …
Preterm Infant Outcomes at 24 Months After Clinician-Supported Web-Based Intervention.
Treyvaud K, Eeles AL, Spittle AJ, Lee KJ, Cheong JLY, Shah P, Doyle LW, Anderson PJ. Treyvaud K, et al. Pediatrics. 2022 Oct 1;150(4):e2021055398. doi: 10.1542/peds.2021-055398. Pediatrics. 2022. PMID: 36130917 Clinical Trial.
The authors of this study evaluated infant and parent outcomes at 12 and 24 months after a clinician-supported, web-based early intervention for preterm infants. ...METHODS: We randomly allocated 103 preterm infants to clinician-supported, web-b …
The authors of this study evaluated infant and parent outcomes at 12 and 24 months after a clinician-supported, web-based early inter …
Lung volume changes during apnoeas in preterm infants.
Gaertner VD, Waldmann AD, Davis PG, Bassler D, Springer L, Tingay DG, Rüegger CM. Gaertner VD, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):170-175. doi: 10.1136/archdischild-2022-324282. Epub 2022 Aug 29. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 36038255 Clinical Trial.
OBJECTIVE: Mechanisms of non-invasive high-frequency oscillatory ventilation (nHFOV) in preterm infants are unclear. We aimed to compare lung volume changes during apnoeas in preterm infants on nHFOV and nasal continuous positive airway pressure (nCPAP …
OBJECTIVE: Mechanisms of non-invasive high-frequency oscillatory ventilation (nHFOV) in preterm infants are unclear. We aimed …
Automatic oxygen control for reducing extremes of oxygen saturation: a randomised controlled trial.
Nair V, Kannan Loganathan P, Lal MK, Pringleton H, Bachman TE, Brodlie M, Dixon P. Nair V, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):136-141. doi: 10.1136/archdischild-2022-324160. Epub 2022 Aug 23. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 35999043 Clinical Trial.
DESIGN: A parallel arm randomised controlled trial. SETTING: A level-III neonatal intensive care unit. PATIENTS: Preterm infants (<33 weeks birth gestation) who received invasive ventilation or NCPAP in the first 72 hours of age. ...CONCLUSIO …
DESIGN: A parallel arm randomised controlled trial. SETTING: A level-III neonatal intensive care unit. PATIENTS: Pre
Text Message Reminders for the Second Dose of Influenza Vaccine for Children: An RCT.
Stockwell MS, Shone LP, Nekrasova E, Wynn C, Torres A, Griffith M, Shults J, Unger R, Ware LA, Kolff C, Harris D, Berrigan L, Montague H, Localio AR, Fiks AG. Stockwell MS, et al. Pediatrics. 2022 Sep 1;150(3):e2022056967. doi: 10.1542/peds.2022-056967. Pediatrics. 2022. PMID: 35965283 Free PMC article. Clinical Trial.
This study sought to compare the effectiveness of text message reminders with embedded interactive educational information versus usual care on receipt and timeliness of the second dose of influenza vaccine. METHODS: This trial took place over the 2017 to 2018 and 2018 to …
This study sought to compare the effectiveness of text message reminders with embedded interactive educational information versus usual c
Low dose paracetamol for management of patent ductus arteriosus in very preterm infants: a randomised non-inferiority trial.
Balasubramanian H, Jain V, Bhalgat P, Parikh S, Kabra N, Mohan D, Sheth K. Balasubramanian H, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):130-135. doi: 10.1136/archdischild-2022-323781. Epub 2022 Aug 8. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 35940873 Clinical Trial.
DESIGN: Single-centre, double-blinded, active controlled, randomised non-inferiority trial. SETTING: Level III neonatal intensive care unit in Western India. PATIENTS: Preterm infants <30 weeks of gestation requiring mechanical ventilation, o …
DESIGN: Single-centre, double-blinded, active controlled, randomised non-inferiority trial. SETTING: Level III neonatal intensive
Outcome at 4.5 years after dextrose gel treatment of hypoglycaemia: follow-up of the Sugar Babies randomised trial.
Harris DL, Gamble GD, Harding JE; CHYLD Study Group. Harris DL, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):121-128. doi: 10.1136/archdischild-2022-324148. Epub 2022 Aug 8. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 35940872 Free PMC article. Clinical Trial.
OBJECTIVE: Dextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown. DESIGN AND SETTING: Follow-up of participants in a randomised trial recruited in a tertiary centre and assessed in a research clinic. ...Children randomised to dextrose gel were …
OBJECTIVE: Dextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown. DESIGN AND SETTING: Follow-up of part …
Remote ischaemic conditioning in necrotising enterocolitis: a phase I feasibility and safety study.
Zozaya C, Ganji N, Li B, Janssen Lok M, Lee C, Koike Y, Gauda E, Offringa M, Eaton S, Shah PS, Pierro A. Zozaya C, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):69-76. doi: 10.1136/archdischild-2022-324174. Epub 2022 Aug 8. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 35940871 Free PMC article. Clinical Trial.
OBJECTIVE: Remote ischaemic conditioning (RIC) improves the outcome of experimental necrotising enterocolitis (NEC) by preserving intestinal microcirculation. The feasibility and safety of RIC in preterm infants with NEC are unknown. The study aimed to assess the fe …
OBJECTIVE: Remote ischaemic conditioning (RIC) improves the outcome of experimental necrotising enterocolitis (NEC) by preserving intestinal …
Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial.
Stahl A, Sukgen EA, Wu WC, Lepore D, Nakanishi H, Mazela J, Moshfeghi DM, Vitti R, Athanikar A, Chu K, Iveli P, Zhao F, Schmelter T, Leal S, Köfüncü E, Azuma N; FIREFLEYE Study Group. Stahl A, et al. JAMA. 2022 Jul 26;328(4):348-359. doi: 10.1001/jama.2022.10564. JAMA. 2022. PMID: 35881122 Free PMC article. Clinical Trial.
INTERVENTIONS: Infants were randomized 2:1 to receive a 0.4-mg dose of intravitreal aflibercept (n = 75) or laser photocoagulation (n = 43) at baseline. ...Three deaths, which occurred 4 to 9 weeks after intravitreal aflibercept treatment, were considered unrelated to afli …
INTERVENTIONS: Infants were randomized 2:1 to receive a 0.4-mg dose of intravitreal aflibercept (n = 75) or laser photocoagulation (n …
Trial of Erythropoietin for Hypoxic-Ischemic Encephalopathy in Newborns.
Wu YW, Comstock BA, Gonzalez FF, Mayock DE, Goodman AM, Maitre NL, Chang T, Van Meurs KP, Lampland AL, Bendel-Stenzel E, Mathur AM, Wu TW, Riley D, Mietzsch U, Chalak L, Flibotte J, Weitkamp JH, Ahmad KA, Yanowitz TD, Baserga M, Poindexter BB, Rogers EE, Lowe JR, Kuban KCK, O'Shea TM, Wisnowski JL, McKinstry RC, Bluml S, Bonifacio S, Benninger KL, Rao R, Smyser CD, Sokol GM, Merhar S, Schreiber MD, Glass HC, Heagerty PJ, Juul SE; HEAL Consortium. Wu YW, et al. N Engl J Med. 2022 Jul 14;387(2):148-159. doi: 10.1056/NEJMoa2119660. N Engl J Med. 2022. PMID: 35830641 Free PMC article. Clinical Trial.
BACKGROUND: Neonatal hypoxic-ischemic encephalopathy is an important cause of death as well as long-term disability in survivors. ...Neurodevelopmental impairment was defined as cerebral palsy, a Gross Motor Function Classification System level of at least 1 (on a scale of …
BACKGROUND: Neonatal hypoxic-ischemic encephalopathy is an important cause of death as well as long-term disability in survivors. ... …
Peer Learning and Mentorship for Neonatal Management Skills: A Cluster-Randomized Trial.
Data S, Mirette D, Cherop M, Bajunirwe F, Kyakwera C, Robinson T, Josephine NN, Abesiga L, Namata T, Brenner JL, Singhal N, Twine M, Wishart I, McIntosh H, Cheng A. Data S, et al. Pediatrics. 2022 Aug 1;150(2):e2021054471. doi: 10.1542/peds.2021-054471. Pediatrics. 2022. PMID: 35794462 Clinical Trial.
BACKGROUND: Clinical knowledge and skills acquired during training programs like Helping Babies Breathe (HBB) and Essential Care for Every Baby (ECEB) decay within weeks or months. We assessed the effect of a peer learning intervention paired with mentorship on retention o …
BACKGROUND: Clinical knowledge and skills acquired during training programs like Helping Babies Breathe (HBB) and Essential Care for …
Effect of Nitric Oxide via Cardiopulmonary Bypass on Ventilator-Free Days in Young Children Undergoing Congenital Heart Disease Surgery: The NITRIC Randomized Clinical Trial.
Schlapbach LJ, Gibbons KS, Horton SB, Johnson K, Long DA, Buckley DHF, Erickson S, Festa M, d'Udekem Y, Alphonso N, Winlaw DS, Delzoppo C, van Loon K, Jones M, Young PJ, Butt W, Schibler A; NITRIC Study Group, the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG), and the ANZICS Paediatric Study Group (PSG). Schlapbach LJ, et al. JAMA. 2022 Jul 5;328(1):38-47. doi: 10.1001/jama.2022.9376. JAMA. 2022. PMID: 35759691 Free PMC article. Clinical Trial.
OBJECTIVE: To determine the effect of nitric oxide applied into the cardiopulmonary bypass oxygenator vs standard care on ventilator-free days in children undergoing surgery for congenital heart disease. ...There were 4 secondary end points including a composite of low car …
OBJECTIVE: To determine the effect of nitric oxide applied into the cardiopulmonary bypass oxygenator vs standard care on ventilator- …
Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial.
Ramnarayan P, Richards-Belle A, Drikite L, Saull M, Orzechowska I, Darnell R, Sadique Z, Lester J, Morris KP, Tume LN, Davis PJ, Peters MJ, Feltbower RG, Grieve R, Thomas K, Mouncey PR, Harrison DA, Rowan KM; FIRST-ABC Step-Up RCT Investigators and the Paediatric Critical Care Society Study Group. Ramnarayan P, et al. JAMA. 2022 Jul 12;328(2):162-172. doi: 10.1001/jama.2022.9615. JAMA. 2022. PMID: 35707984 Free PMC article. Clinical Trial.
DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, multicenter, randomized noninferiority clinical trial conducted in 24 pediatric critical care units in the United Kingdom among 600 acutely ill children aged 0 to 15 years who were clinically assessed to require noninvas …
DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, multicenter, randomized noninferiority clinical trial conducted in 24 pediatric critical ca
Maternal High-Dose DHA Supplementation and Neurodevelopment at 18-22 Months of Preterm Children.
Guillot M, Synnes A, Pronovost E, Qureshi M, Daboval T, Caouette G, Olivier F, Bartholomew J, Mohamed I, Massé E, Afifi J, Hendson L, Lemyre B, Luu TM, Strueby L, Cieslak Z, Yusuf K, Pelligra G, Ducruet T, Ndiaye ABKT, Angoa G, Sériès T, Piedboeuf B, Nuyt AM, Fraser W, Mâsse B, Lacaze-Masmonteil T, Lavoie PM, Marc I. Guillot M, et al. Pediatrics. 2022 Jul 1;150(1):e2021055819. doi: 10.1542/peds.2021-055819. Pediatrics. 2022. PMID: 35652296 Clinical Trial.
OBJECTIVES: To determine whether maternal supplementation with high-dose docosahexaenoic acid (DHA) in breastfed, very preterm neonates improves neurodevelopmental outcomes at 18 to 22 months' corrected age (CA). ...CONCLUSIONS: Maternal DHA supplementation did not …
OBJECTIVES: To determine whether maternal supplementation with high-dose docosahexaenoic acid (DHA) in breastfed, very preterm neo
Short-term pulmonary and systemic effects of hydrocortisone initiated 7-14 days after birth in ventilated very preterm infants: a secondary analysis of a randomised controlled trial.
Halbmeijer NM, Onland W, Cools F, Kroon A, van der Heide-Jalving M, Dijk P, van Straaten HLM, Te Pas AB, Mohns T, Bruneel E, van Heijst AFJ, Kramer B, Debeer A, Zonnenberg IA, Marechal Y, Blom H, Plaskie K, Merkus MP, Offringa M, van Kaam AH; SToP-BPD Study Group; STOP-BPD Study Group. Halbmeijer NM, et al. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):20-25. doi: 10.1136/archdischild-2022-323882. Epub 2022 May 9. Arch Dis Child Fetal Neonatal Ed. 2023. PMID: 35534184 Clinical Trial.
OBJECTIVE: Observational studies in preterm infants suggest that systemic hydrocortisone improves pulmonary condition but may also lead to systemic adverse effects. ...DESIGN: Randomised placebo-controlled trial. SETTING: Dutch and Belgian neonatal intensi
OBJECTIVE: Observational studies in preterm infants suggest that systemic hydrocortisone improves pulmonary condition but may …
Nasal High-Flow Therapy during Neonatal Endotracheal Intubation.
Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Hodgson KA, et al. N Engl J Med. 2022 Apr 28;386(17):1627-1637. doi: 10.1056/NEJMoa2116735. N Engl J Med. 2022. PMID: 35476651 Clinical Trial.
It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in children and adults receiving general anesthesia, can improve the likelihood of successful neonatal intubation on the first attempt. METHODS: We performed a …
It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in children and adults rece …
Noninvasive Neurally Adjusted Ventilation in Postextubation Stabilization of Preterm Infants: A Randomized Controlled Study.
Shin SH, Shin SH, Kim SH, Song IG, Jung YH, Kim EK, Kim HS. Shin SH, et al. J Pediatr. 2022 Aug;247:53-59.e1. doi: 10.1016/j.jpeds.2022.04.025. Epub 2022 Apr 20. J Pediatr. 2022. PMID: 35460702 Clinical Trial.
OBJECTIVE: To compare the effects of noninvasive neurally adjusted ventilatory assist (NIV-NAVA) to nasal continuous positive airway pressure (NCPAP) in achieving successful extubation in preterm infants. STUDY DESIGN: This prospective, single-center, randomized con …
OBJECTIVE: To compare the effects of noninvasive neurally adjusted ventilatory assist (NIV-NAVA) to nasal continuous positive airway pressur …
25% Dextrose Versus 24% Sucrose for Heel Lancing in Preterm Infants: A Noninferiority RCT.
Sasidharan R, Gupta N, Yadav B, Chawla D, Singh K, Kumarendu Singh A. Sasidharan R, et al. Pediatrics. 2022 May 1;149(5):e2021054618. doi: 10.1542/peds.2021-054618. Pediatrics. 2022. PMID: 35451020 Clinical Trial.
OBJECTIVES: To compare the efficacy of 25% dextrose with 24% sucrose for heel-lance analgesia in preterm infants admitted to the NICU. METHODS: In this noninferiority, double-blind, randomized controlled trial, preterm infants born at 28 weeks a …
OBJECTIVES: To compare the efficacy of 25% dextrose with 24% sucrose for heel-lance analgesia in preterm infants admitted to t …
Efficacy, safety, and immunogenicity of an inactivated, adjuvanted enterovirus 71 vaccine in infants and children: a multiregion, double-blind, randomised, placebo-controlled, phase 3 trial.
Nguyen TT, Chiu CH, Lin CY, Chiu NC, Chen PY, Le TTV, Le DN, Duong AH, Nguyen VL, Huynh TN, Truong HK, Phan TL, Nguyen TTT, Shih SR, Huang CG, Weng YJ, Hsieh EF, Chang S, Chen C, Tai IC, Huang LM. Nguyen TT, et al. Lancet. 2022 Apr 30;399(10336):1708-1717. doi: 10.1016/S0140-6736(22)00313-0. Epub 2022 Apr 12. Lancet. 2022. PMID: 35427481 Clinical Trial.
Remote Stewardship for Medically Underserved Nurseries: A Stepped-Wedge, Cluster Randomized Study.
Cantey JB, Correa CC, Dugi DD, Huff E, Olaya JE, Farner R. Cantey JB, et al. Pediatrics. 2022 May 1;149(5):e2021055686. doi: 10.1542/peds.2021-055686. Pediatrics. 2022. PMID: 35411402 Free PMC article. Clinical Trial.
RESULTS: During the study period, there were 9277 infants born (4586 preintervention, 4691 postintervention). Infants exposed to antibiotics declined from 6.2% pre-ASP to 4.2% post-ASP (relative risk 0.68 [95% confidence interval, 0.63% to 0.75%]). ...Remote steward …
RESULTS: During the study period, there were 9277 infants born (4586 preintervention, 4691 postintervention). Infants exposed …
Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Following Extubation on Liberation From Respiratory Support in Critically Ill Children: A Randomized Clinical Trial.
Ramnarayan P, Richards-Belle A, Drikite L, Saull M, Orzechowska I, Darnell R, Sadique Z, Lester J, Morris KP, Tume LN, Davis PJ, Peters MJ, Feltbower RG, Grieve R, Thomas K, Mouncey PR, Harrison DA, Rowan KM; FIRST-ABC Step-Down RCT Investigators and the Paediatric Critical Care Society Study Group. Ramnarayan P, et al. JAMA. 2022 Apr 26;327(16):1555-1565. doi: 10.1001/jama.2022.3367. JAMA. 2022. PMID: 35390113 Free PMC article. Clinical Trial.
DESIGN, SETTING, AND PARTICIPANTS: This was a pragmatic, multicenter, randomized, noninferiority trial conducted at 22 pediatric intensive care units in the United Kingdom. Six hundred children aged 0 to 15 years clinically assessed to require noninvasive res …
DESIGN, SETTING, AND PARTICIPANTS: This was a pragmatic, multicenter, randomized, noninferiority trial conducted at 22 pediatric intensiv
Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia.
Watterberg KL, Walsh MC, Li L, Chawla S, D'Angio CT, Goldberg RN, Hintz SR, Laughon MM, Yoder BA, Kennedy KA, McDavid GE, Backstrom-Lacy C, Das A, Crawford MM, Keszler M, Sokol GM, Poindexter BB, Ambalavanan N, Hibbs AM, Truog WE, Schmidt B, Wyckoff MH, Khan AM, Garg M, Chess PR, Reynolds AM, Moallem M, Bell EF, Meyer LR, Patel RM, Van Meurs KP, Cotten CM, McGowan EC, Hines AC, Merhar S, Peralta-Carcelen M, Wilson-Costello DE, Kilbride HW, DeMauro SB, Heyne RJ, Mosquera RA, Natarajan G, Purdy IB, Lowe JR, Maitre NL, Harmon HM, Hogden LA, Adams-Chapman I, Winter S, Malcolm WF, Higgins RD; Eunice Kennedy Shriver NICHD Neonatal Research Network. Watterberg KL, et al. N Engl J Med. 2022 Mar 24;386(12):1121-1131. doi: 10.1056/NEJMoa2114897. N Engl J Med. 2022. PMID: 35320643 Free PMC article. Clinical Trial.
Two-year outcomes were known for 91.0% of the infants. Survival without moderate or severe neurodevelopmental impairment occurred in 132 of 358 infants (36.9%) in the hydrocortisone group and in 134 of 359 (37.3%) in the placebo group (adjusted rate ratio, 0.98; 95% …
Two-year outcomes were known for 91.0% of the infants. Survival without moderate or severe neurodevelopmental impairment occurred in …
Prophylactic Oral Dextrose Gel and Neurosensory Impairment at 2-Year Follow-up of Participants in the hPOD Randomized Trial.
Edwards T, Alsweiler JM, Crowther CA, Edlin R, Gamble GD, Hegarty JE, Lin L, McKinlay CJD, Rogers JA, Thompson B, Wouldes TA, Harding JE. Edwards T, et al. JAMA. 2022 Mar 22;327(12):1149-1157. doi: 10.1001/jama.2022.2363. JAMA. 2022. PMID: 35315885 Free PMC article. Clinical Trial.
Participants were late preterm or term at-risk infants; those randomized in 9 New Zealand centers (n = 1359) were included and followed up between January 2017 and July 2021. ...There were no significant differences between groups in the other 27 secondary outcomes. …
Participants were late preterm or term at-risk infants; those randomized in 9 New Zealand centers (n = 1359) were included and …
Thirteen-Year Outcomes of a Randomized Clinical Trial of Early Preventive Care for Very Preterm Infants and Their Parents.
Stedall PM, Spencer-Smith MM, Mainzer RM, Treyvaud K, Burnett AC, Doyle LW, Spittle AJ, Anderson PJ. Stedall PM, et al. J Pediatr. 2022 Jul;246:80-88.e4. doi: 10.1016/j.jpeds.2022.03.013. Epub 2022 Mar 16. J Pediatr. 2022. PMID: 35304169 Clinical Trial.
OBJECTIVE: To evaluate 13-year outcomes of a randomized controlled trial of preventive care (VIBeS Plus) for infants born very preterm and their parents and examine whether possible effects of intervention varied by family social risk. STUDY DESIGN: Families …
OBJECTIVE: To evaluate 13-year outcomes of a randomized controlled trial of preventive care (VIBeS Plus) for infants born very …
Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children.
Turkova A, Wills GH, Wobudeya E, Chabala C, Palmer M, Kinikar A, Hissar S, Choo L, Musoke P, Mulenga V, Mave V, Joseph B, LeBeau K, Thomason MJ, Mboizi RB, Kapasa M, van der Zalm MM, Raichur P, Bhavani PK, McIlleron H, Demers AM, Aarnoutse R, Love-Koh J, Seddon JA, Welch SB, Graham SM, Hesseling AC, Gibb DM, Crook AM; SHINE Trial Team. Turkova A, et al. N Engl J Med. 2022 Mar 10;386(10):911-922. doi: 10.1056/NEJMoa2104535. N Engl J Med. 2022. PMID: 35263517 Free PMC article. Clinical Trial.
Effect of Physiologic Point-of-Care Cardiopulmonary Resuscitation Training on Survival With Favorable Neurologic Outcome in Cardiac Arrest in Pediatric ICUs: A Randomized Clinical Trial.
ICU-RESUS and Eunice Kennedy Shriver National Institute of Child Health; Human Development Collaborative Pediatric Critical Care Research Network Investigator Groups; Sutton RM, Wolfe HA, Reeder RW, Ahmed T, Bishop R, Bochkoris M, Burns C, Diddle JW, Federman M, Fernandez R, Franzon D, Frazier AH, Friess SH, Graham K, Hehir D, Horvat CM, Huard LL, Landis WP, Maa T, Manga A, Morgan RW, Nadkarni VM, Naim MY, Palmer CA, Schneiter C, Sharron MP, Siems A, Srivastava N, Tabbutt S, Tilford B, Viteri S, Berg RA, Bell MJ, Carcillo JA, Carpenter TC, Dean JM, Fink EL, Hall M, McQuillen PS, Meert KL, Mourani PM, Notterman D, Pollack MM, Sapru A, Wessel D, Yates AR, Zuppa AF. ICU-RESUS and Eunice Kennedy Shriver National Institute of Child Health, et al. JAMA. 2022 Mar 8;327(10):934-945. doi: 10.1001/jama.2022.1738. JAMA. 2022. PMID: 35258533 Free PMC article. Clinical Trial.
OBJECTIVE: To evaluate the effectiveness of a bundled intervention comprising physiologically focused CPR training at the point of care and structured clinical event debriefings. DESIGN, SETTING, AND PARTICIPANTS: A parallel, hybrid stepped-wedge, cluster randomized trial …
OBJECTIVE: To evaluate the effectiveness of a bundled intervention comprising physiologically focused CPR training at the point of care
A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome.
Dani C, Talosi G, Piccinno A, Ginocchio VM, Balla G, Lavizzari A, Stranak Z, Gitto E, Martinelli S, Plavka R, Krolak-Olejnik B, Lista G, Spedicato F, Ciurlia G, Santoro D, Sweet D; CURONEB Study Group. Dani C, et al. J Pediatr. 2022 Jul;246:40-47.e5. doi: 10.1016/j.jpeds.2022.02.054. Epub 2022 Mar 5. J Pediatr. 2022. PMID: 35257740 Free article. Clinical Trial.
Secondary outcomes included the time to respiratory failure in the first 72 hours, duration of ventilation, mortality, incidence of bronchopulmonary dysplasia, and major associated neonatal comorbidities. In addition, the safety and tolerability of the treatments were asse …
Secondary outcomes included the time to respiratory failure in the first 72 hours, duration of ventilation, mortality, incidence of bronchop …
Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity.
Domachowske J, Madhi SA, Simões EAF, Atanasova V, Cabañas F, Furuno K, Garcia-Garcia ML, Grantina I, Nguyen KA, Brooks D, Chang Y, Leach A, Takas T, Yuan Y, Griffin MP, Mankad VS, Villafana T; MEDLEY Study Group. Domachowske J, et al. N Engl J Med. 2022 Mar 3;386(9):892-894. doi: 10.1056/NEJMc2112186. N Engl J Med. 2022. PMID: 35235733 Clinical Trial. No abstract available.
Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants.
Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wählby Hamrén U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Hammitt LL, et al. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275. N Engl J Med. 2022. PMID: 35235726 Clinical Trial.
The efficacy and safety of nirsevimab in healthy late-preterm and term infants are uncertain. METHODS: We randomly assigned, in a 2:1 ratio, infants who had been born at a gestational age of at least 35 weeks to receive a single intramuscular injection of nir …
The efficacy and safety of nirsevimab in healthy late-preterm and term infants are uncertain. METHODS: We randomly assigned, i …
Influence of Genetic Information on Neonatologists' Decisions: A Psychological Experiment.
Callahan KP, Flibotte J, Skraban C, Wild KT, Joffe S, Munson D, Feudtner C. Callahan KP, et al. Pediatrics. 2022 Mar 1;149(3):e2021052130. doi: 10.1542/peds.2021-052130. Pediatrics. 2022. PMID: 35169841 Free PMC article. Clinical Trial.
With this study, we sought to determine how different types of genetic information with uncertain implications for prognosis influence clinicians' decisions to recommend intensive versus palliative care. METHODS: We conducted a national study of neonatologists using …
With this study, we sought to determine how different types of genetic information with uncertain implications for prognosis influence clini …
Lung volume distribution in preterm infants on non-invasive high-frequency ventilation.
Gaertner VD, Waldmann AD, Davis PG, Bassler D, Springer L, Thomson J, Tingay DG, Rüegger CM. Gaertner VD, et al. Arch Dis Child Fetal Neonatal Ed. 2022 Sep;107(5):551-557. doi: 10.1136/archdischild-2021-322990. Epub 2022 Jan 31. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 35101993 Clinical Trial.
INTRODUCTION: Non-invasive high-frequency oscillatory ventilation (nHFOV) is an extension of nasal continuous positive airway pressure (nCPAP) support in neonates. We aimed to compare global and regional distribution of lung volumes during nHFOV versus nCPAP. METHODS: In 3 …
INTRODUCTION: Non-invasive high-frequency oscillatory ventilation (nHFOV) is an extension of nasal continuous positive airway pressure (nCPA …
Pragmatic Randomized Trial of Corticosteroids and Inhaled Epinephrine for Bronchiolitis in Children in Intensive Care.
Gelbart B, McSharry B, Delzoppo C, Erickson S, Lee K, Butt W, Rea M, Wang X, Beca J, Kazemi A, Shann F. Gelbart B, et al. J Pediatr. 2022 May;244:17-23.e1. doi: 10.1016/j.jpeds.2022.01.031. Epub 2022 Jan 31. J Pediatr. 2022. PMID: 35093318 Clinical Trial.
OBJECTIVE: To determine whether the combination of systemic corticosteroids and nebulized epinephrine, compared with standard care, reduces the duration of positive pressure support in children with bronchiolitis admitted to intensive care. ...The primary out …
OBJECTIVE: To determine whether the combination of systemic corticosteroids and nebulized epinephrine, compared with standard care, r …
An educational programme in neonatal intensive care units (SEPREVEN): a stepped-wedge, cluster-randomised controlled trial.
Caeymaex L, Astruc D, Biran V, Marcus L, Flamein F, Le Bouedec S, Guillois B, Remichi R, Harbi F, Durrmeyer X, Casagrande F, Le Saché N, Todorova D, Bilal A, Olivier D, Reynaud A, Jacquin C, Rozé JC, Layese R, Danan C, Jung C, Decobert F, Audureau E. Caeymaex L, et al. Lancet. 2022 Jan 22;399(10322):384-392. doi: 10.1016/S0140-6736(21)01899-7. Lancet. 2022. PMID: 35065786 Clinical Trial.
BACKGROUND: Patients in neonatal intensive care units (NICUs) are at high risk of adverse events. ...METHODS: In this multicentre, stepped-wedge, cluster-randomised controlled trial done in France, we randomly assigned 12 NICUs to three clusters of fou …
BACKGROUND: Patients in neonatal intensive care units (NICUs) are at high risk of adverse events. ...METHODS: In …
Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes.
Ware J, Allen JM, Boughton CK, Wilinska ME, Hartnell S, Thankamony A, de Beaufort C, Schierloh U, Fröhlich-Reiterer E, Mader JK, Kapellen TM, Rami-Merhar B, Tauschmann M, Nagl K, Hofer SE, Campbell FM, Yong J, Hood KK, Lawton J, Roze S, Sibayan J, Bocchino LE, Kollman C, Hovorka R; KidsAP Consortium. Ware J, et al. N Engl J Med. 2022 Jan 20;386(3):209-219. doi: 10.1056/NEJMoa2111673. N Engl J Med. 2022. PMID: 35045227 Clinical Trial.
Improving Underweight Mothers' Essential Newborn Care During Early Infancy: A Single-Blinded, Parallel-Randomized, Controlled Trial.
Singh N, Rao SS, Mithra P, Manjrekar P, Kamath N, Baliga BS. Singh N, et al. J Pediatr. 2022 May;244:72-78.e2. doi: 10.1016/j.jpeds.2022.01.005. Epub 2022 Jan 14. J Pediatr. 2022. PMID: 35033564 Clinical Trial.
OBJECTIVE: To evaluate the effectiveness of using a standardized Essential Newborn Care (ENC) module taught by pediatric residents on ENC skills and growth of offspring born to underweight primigravida mothers. ...A trained hospital nurse, blinded to the study, asse …
OBJECTIVE: To evaluate the effectiveness of using a standardized Essential Newborn Care (ENC) module taught by pediatric resid …
Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous Thromboembolism: The Kids-DOTT Randomized Clinical Trial.
Goldenberg NA, Kittelson JM, Abshire TC, Bonaca M, Casella JF, Dale RA, Halperin JL, Hamblin F, Kessler CM, Manco-Johnson MJ, Sidonio RF, Spyropoulos AC, Steg PG, Turpie AGG, Schulman S; Kids-DOTT Trial Investigators and the ATLAS Group. Goldenberg NA, et al. JAMA. 2022 Jan 11;327(2):129-137. doi: 10.1001/jama.2021.23182. JAMA. 2022. PMID: 35015038 Free PMC article. Clinical Trial.
Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial.
Gaden TS, Ghetti C, Kvestad I, Bieleninik Ł, Stordal AS, Assmus J, Arnon S, Elefant C, Epstein S, Ettenberger M, Lichtensztejn M, Lindvall MW, Mangersnes J, Røed CJ, Vederhus BJ, Gold C. Gaden TS, et al. Pediatrics. 2022 Feb 1;149(2):e2021052797. doi: 10.1542/peds.2021-052797. Pediatrics. 2022. PMID: 34988583 Clinical Trial.
OBJECTIVES: To evaluate short-term effects of music therapy (MT) for premature infants and their caregivers on mother-infant bonding, parental anxiety, and maternal depression. ...MT included 3 sessions per week with parent-led, infant-directed singing suppor …
OBJECTIVES: To evaluate short-term effects of music therapy (MT) for premature infants and their caregivers on mother-infant b …
Trial of Three Rounds of Mass Azithromycin Administration for Yaws Eradication.
John LN, Beiras CG, Houinei W, Medappa M, Sabok M, Kolmau R, Jonathan E, Maika E, Wangi JK, Pospíšilová P, Šmajs D, Ouchi D, Galván-Femenía I, Beale MA, Giacani L, Clotet B, Mooring EQ, Marks M, Vall-Mayans M, Mitjà O. John LN, et al. N Engl J Med. 2022 Jan 6;386(1):47-56. doi: 10.1056/NEJMoa2109449. N Engl J Med. 2022. PMID: 34986286 Free PMC article. Clinical Trial.
Lower Maternal Chronic Physiological Stress and Better Child Behavior at 18 Months: Follow-Up of a Cluster Randomized Trial of Neonatal Intensive Care Unit Family Integrated Care.
Mclean MA, Scoten OC, Yu W, Ye XY, Petrie J, Church PT, Soraisham AS, Mirea LS, Weinberg J, Synnes AR, O'Brien K, Grunau RE. Mclean MA, et al. J Pediatr. 2022 Apr;243:107-115.e4. doi: 10.1016/j.jpeds.2021.12.055. Epub 2021 Dec 29. J Pediatr. 2022. PMID: 34971651 Clinical Trial.
OBJECTIVE: To assess whether Family Integrated Care (FICare) in the neonatal intensive care unit improves maternal chronic physiological stress and child behavior at 18 months of corrected age for infants born preterm. STUDY DESIGN: Follo …
OBJECTIVE: To assess whether Family Integrated Care (FICare) in the neonatal intensive care unit improves matern …
Randomized Trial of Perfusion-Based Circulatory Management in Infants of Very Low Birth Weight.
Ishiguro A, Sasaki A, Motojima Y, Oka S, Nishiguchi R, Nakagawa R, Nishimura E, Iwatani A, Iwasaki Y, Miyahara N, Saito K, Haga M, Ito K, Kanai M, Hussein MH, Kabe K. Ishiguro A, et al. J Pediatr. 2022 Apr;243:27-32.e2. doi: 10.1016/j.jpeds.2021.12.020. Epub 2021 Dec 21. J Pediatr. 2022. PMID: 34942176 Clinical Trial.
Infants with VLBW were assigned randomly to a BF-based group or BP-based (BP group) circulatory management group. ...In BF group, the IVH incidence rate was significantly greater in infants with unsuccessful intervention when compared with healthy individuals (6% vs
Infants with VLBW were assigned randomly to a BF-based group or BP-based (BP group) circulatory management group. ...In BF group, the
Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial.
Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Özkan H, Hulzebos CV, Schmölzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Tauscher MK, Murthy V, Ali SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Dargaville PA, et al. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892. JAMA. 2021. PMID: 34902013 Free PMC article. Clinical Trial.
IMPORTANCE: The benefits of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome are uncertain. ...The trial was conducted at 33 tertiary-level neonatal intensive
IMPORTANCE: The benefits of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm
Effects of tactile stimulation on spontaneous breathing during face mask ventilation.
Gaertner VD, Rüegger CM, Bassler D, O'Currain E, Kamlin COF, Hooper SB, Davis PG, Springer L. Gaertner VD, et al. Arch Dis Child Fetal Neonatal Ed. 2022 Sep;107(5):508-512. doi: 10.1136/archdischild-2021-322989. Epub 2021 Dec 3. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34862191 Clinical Trial.
DESIGN: Secondary analysis of a prospective, randomised trial comparing two face masks. SETTING: Single-centre delivery room study. PATIENTS: Newborn infants 34 weeks' gestation at birth. METHODS: Resuscitations were video recorded. ...These data inform the discussi …
DESIGN: Secondary analysis of a prospective, randomised trial comparing two face masks. SETTING: Single-centre delivery room study. PATIENTS …
Intranasal Surfactant for Acute Otitis Media: A Randomized Trial.
Muniz GB, Shope TR, Bhatnagar S, Shaikh N, Haralam MA, Liu H, Martin JM, Pogoda JM, Hoberman A. Muniz GB, et al. Pediatrics. 2021 Dec 1;148(6):e2021051703. doi: 10.1542/peds.2021-051703. Pediatrics. 2021. PMID: 34851411 Clinical Trial.
Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants.
Schwarz CE, Kreutzer KB, Langanky L, Wolf NS, Braun W, O'Sullivan MP, Poets CF, Franz AR. Schwarz CE, et al. Arch Dis Child Fetal Neonatal Ed. 2022 Jul;107(4):425-430. doi: 10.1136/archdischild-2021-322096. Epub 2021 Nov 24. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34819347 Clinical Trial.
OBJECTIVE: Automatic control (SPOC) of the fraction of inspired oxygen (FiO(2)), based on continuous analysis of pulse oximeter saturation (SpO(2)), improves the proportion of time preterm infants spend within a specified SpO(2)-target range (Target%). ...A generate …
OBJECTIVE: Automatic control (SPOC) of the fraction of inspired oxygen (FiO(2)), based on continuous analysis of pulse oximeter saturation ( …
Child Care Center Hand Hygiene Programs' Cost-Effectiveness in Preventing Respiratory Infections.
Azor-Martinez E, Garcia-Mochon L, Lopez-Lacort M, Strizzi JM, Muñoz-Vico FJ, Jimenez-Lorente CP, Fernandez-Campos MA, Bueno-Rebollo C, Del Castillo-Aguas G, Balaguer-Martinez JV, Gimenez-Sanchez F. Azor-Martinez E, et al. Pediatrics. 2021 Dec 1;148(6):e2021052496. doi: 10.1542/peds.2021-052496. Pediatrics. 2021. PMID: 34814193 Clinical Trial.
BACKGROUND: We previously demonstrated that a hand hygiene program, including hand sanitizer and educational measures, for day care center (DCC) staff, children, and parents was more effective than a soap-and-water program, with initial observation, in preventing respirato …
BACKGROUND: We previously demonstrated that a hand hygiene program, including hand sanitizer and educational measures, for day care c …
Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study.
Gonzales E, Hardikar W, Stormon M, Baker A, Hierro L, Gliwicz D, Lacaille F, Lachaux A, Sturm E, Setchell KDR, Kennedy C, Dorenbaum A, Steinmetz J, Desai NK, Wardle AJ, Garner W, Vig P, Jaecklin T, Sokal EM, Jacquemin E. Gonzales E, et al. Lancet. 2021 Oct 30;398(10311):1581-1592. doi: 10.1016/S0140-6736(21)01256-3. Epub 2021 Oct 28. Lancet. 2021. PMID: 34755627 Clinical Trial.
Effect of Amoxicillin Dose and Treatment Duration on the Need for Antibiotic Re-treatment in Children With Community-Acquired Pneumonia: The CAP-IT Randomized Clinical Trial.
Bielicki JA, Stöhr W, Barratt S, Dunn D, Naufal N, Roland D, Sturgeon K, Finn A, Rodriguez-Ruiz JP, Malhotra-Kumar S, Powell C, Faust SN, Alcock AE, Hall D, Robinson G, Hawcutt DB, Lyttle MD, Gibb DM, Sharland M; PERUKI, GAPRUKI, and the CAP-IT Trial Group. Bielicki JA, et al. JAMA. 2021 Nov 2;326(17):1713-1724. doi: 10.1001/jama.2021.17843. JAMA. 2021. PMID: 34726708 Free PMC article. Clinical Trial.
A Pilot Randomized Trial of Heart Rate Monitoring Using Conventional Versus a New Electrocardiogram Algorithm during Neonatal Resuscitation at Birth.
Katheria AC, Morales A, Shashank S, Rich WD, Finer NN. Katheria AC, et al. J Pediatr. 2022 Mar;242:245-247.e1. doi: 10.1016/j.jpeds.2021.10.037. Epub 2021 Oct 27. J Pediatr. 2022. PMID: 34715091 Clinical Trial.
Current guidelines support the use of a cardiac monitor during neonatal resuscitation. Infants born preterm randomized to a novel electrocardiogram algorithm displayed a heart rate sooner than the conventional electrocardiogram algorithm. Although resuscitati …
Current guidelines support the use of a cardiac monitor during neonatal resuscitation. Infants born preterm randomized …
Randomized Trial to Increase Speech Sound Differentiation in Infants Born Preterm.
Richard C, Jeanvoine A, Stark AR, Hague K, Kjeldsen C, Maitre NL. Richard C, et al. J Pediatr. 2022 Feb;241:103-108.e3. doi: 10.1016/j.jpeds.2021.10.035. Epub 2021 Oct 25. J Pediatr. 2022. PMID: 34710395 Clinical Trial.
STUDY DESIGN: Pilot randomized controlled trial of stable infants born preterm in the newborn intensive care unit with normal auditory brainstem responses, whose parents spoke only English and had no musical training or familial hearing abnormal …
STUDY DESIGN: Pilot randomized controlled trial of stable infants born preterm in the newborn intensive care
Do Extremely Low Gestational Age Neonates Regulate Iron Absorption via Hepcidin?
German KR, Comstock BA, Parikh P, Whittington D, Mayock DE, Heagerty PJ, Bahr TM, Juul SE. German KR, et al. J Pediatr. 2022 Feb;241:62-67.e1. doi: 10.1016/j.jpeds.2021.09.059. Epub 2021 Oct 7. J Pediatr. 2022. PMID: 34626672 Free PMC article. Clinical Trial.
OBJECTIVES: To evaluate whether extremely preterm infants regulate iron status via hepcidin. STUDY DESIGN: In this retrospective analysis of infants from the Preterm Epo Neuroprotection (PENUT) Trial, urine hepcidin (Uhep) normalized to creatinine (Uhe …
OBJECTIVES: To evaluate whether extremely preterm infants regulate iron status via hepcidin. STUDY DESIGN: In this retrospecti …
Antibiotics for lower respiratory tract infection in children presenting in primary care in England (ARTIC PC): a double-blind, randomised, placebo-controlled trial.
Little P, Francis NA, Stuart B, O'Reilly G, Thompson N, Becque T, Hay AD, Wang K, Sharland M, Harnden A, Yao G, Raftery J, Zhu S, Little J, Hookham C, Rowley K, Euden J, Harman K, Coenen S, Read RC, Woods C, Butler CC, Faust SN, Leydon G, Wan M, Hood K, Whitehurst J, Richards-Hall S, Smith P, Thomas M, Moore M, Verheij T. Little P, et al. Lancet. 2021 Oct 16;398(10309):1417-1426. doi: 10.1016/S0140-6736(21)01431-8. Epub 2021 Sep 22. Lancet. 2021. PMID: 34562391 Free PMC article. Clinical Trial.
In ARTIC PC, we assessed whether amoxicillin reduces the duration of moderately bad symptoms in children presenting with uncomplicated (non-pneumonic) LRTI in primary care, overall and in key clinical subgroups. METHODS: ARTIC PC was a double-blind, randomised, placebo-con …
In ARTIC PC, we assessed whether amoxicillin reduces the duration of moderately bad symptoms in children presenting with uncomplicated (non- …
Safety and Efficacy of a Typhoid Conjugate Vaccine in Malawian Children.
Patel PD, Patel P, Liang Y, Meiring JE, Misiri T, Mwakiseghile F, Tracy JK, Masesa C, Msuku H, Banda D, Mbewe M, Henrion M, Adetunji F, Simiyu K, Rotrosen E, Birkhold M, Nampota N, Nyirenda OM, Kotloff K, Gmeiner M, Dube Q, Kawalazira G, Laurens MB, Heyderman RS, Gordon MA, Neuzil KM; TyVAC Malawi Team. Patel PD, et al. N Engl J Med. 2021 Sep 16;385(12):1104-1115. doi: 10.1056/NEJMoa2035916. N Engl J Med. 2021. PMID: 34525285 Free PMC article. Clinical Trial.
Benefits and Risks of Iron Interventions in Infants in Rural Bangladesh.
Pasricha SR, Hasan MI, Braat S, Larson LM, Tipu SMM, Hossain SJ, Shiraji S, Baldi A, Bhuiyan MSA, Tofail F, Fisher J, Grantham-McGregor S, Simpson JA, Hamadani JD, Biggs BA. Pasricha SR, et al. N Engl J Med. 2021 Sep 9;385(11):982-995. doi: 10.1056/NEJMoa2034187. N Engl J Med. 2021. PMID: 34496174 Clinical Trial.
The primary outcome was cognitive development, as assessed by the cognitive composite score on the Bayley Scales of Infant and Toddler Development, third edition, immediately after completion of the assigned 3-month regimen; scores range from 55 to 145, with higher scores …
The primary outcome was cognitive development, as assessed by the cognitive composite score on the Bayley Scales of Infant and Toddle …
Impact of personal protective equipment on neonatal resuscitation procedures: a randomised, cross-over, simulation study.
Cavallin F, Lupi F, Bua B, Bellutti M, Staffler A, Trevisanuto D. Cavallin F, et al. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):211-215. doi: 10.1136/archdischild-2021-322216. Epub 2021 Sep 6. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34489350 Clinical Trial.
BACKGROUND AND OBJECTIVE: Healthcare providers should use personal protective equipment (PPE) when performing aerosol-generating medical procedures during highly infectious respiratory pandemics. We aimed to compare the timing of neonatal resuscitation procedures in a mani …
BACKGROUND AND OBJECTIVE: Healthcare providers should use personal protective equipment (PPE) when performing aerosol-generating medical pro …
Association between Term Equivalent Brain Magnetic Resonance Imaging and 2-Year Outcomes in Extremely Preterm Infants: A Report from the Preterm Erythropoietin Neuroprotection Trial Cohort.
Mayock DE, Gogcu S, Puia-Dumitrescu M, Shaw DWW, Wright JN, Comstock BA, Heagerty PJ, Juul SE; Preterm Erythropoietin Neuroprotection (PENUT) Trial Consortium. Mayock DE, et al. J Pediatr. 2021 Dec;239:117-125.e6. doi: 10.1016/j.jpeds.2021.08.040. Epub 2021 Aug 26. J Pediatr. 2021. PMID: 34454953 Free PMC article. Clinical Trial.
STUDY DESIGN: The association between brain abnormality scores and Bayley Scales of Infant Development, Third Edition at 2 years corrected age was explored in a subset of infants enrolled in the Preterm Erythropoietin Neuroprotection Trial. ...CONCLUSIONS: Ev …
STUDY DESIGN: The association between brain abnormality scores and Bayley Scales of Infant Development, Third Edition at 2 years corr …
Sustained Inflation Versus Intermittent Positive Pressure Ventilation for Preterm Infants at Birth: Respiratory Function and Vital Sign Measurements.
Foglia EE, Kirpalani H, Ratcliffe SJ, Davis PG, Thio M, Hummler H, Lista G, Cavigioli F, Schmölzer GM, Keszler M, Te Pas AB. Foglia EE, et al. J Pediatr. 2021 Dec;239:150-154.e1. doi: 10.1016/j.jpeds.2021.08.038. Epub 2021 Aug 25. J Pediatr. 2021. PMID: 34453917 Free PMC article. Clinical Trial.
OBJECTIVE: To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered noninvasively to infants in the Sustained Aeration of Infant Lungs (SAIL) trial and to compare vital si …
OBJECTIVE: To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventil …
Seasonal Malaria Vaccination with or without Seasonal Malaria Chemoprevention.
Chandramohan D, Zongo I, Sagara I, Cairns M, Yerbanga RS, Diarra M, Nikièma F, Tapily A, Sompougdou F, Issiaka D, Zoungrana C, Sanogo K, Haro A, Kaya M, Sienou AA, Traore S, Mahamar A, Thera I, Diarra K, Dolo A, Kuepfer I, Snell P, Milligan P, Ockenhouse C, Ofori-Anyinam O, Tinto H, Djimde A, Ouédraogo JB, Dicko A, Greenwood B. Chandramohan D, et al. N Engl J Med. 2021 Sep 9;385(11):1005-1017. doi: 10.1056/NEJMoa2026330. Epub 2021 Aug 25. N Engl J Med. 2021. PMID: 34432975 Clinical Trial.
Protection by vaccination of children against typhoid fever with a Vi-tetanus toxoid conjugate vaccine in urban Bangladesh: a cluster-randomised trial.
Qadri F, Khanam F, Liu X, Theiss-Nyland K, Biswas PK, Bhuiyan AI, Ahmmed F, Colin-Jones R, Smith N, Tonks S, Voysey M, Mujadidi YF, Mazur O, Rajib NH, Hossen MI, Ahmed SU, Khan A, Rahman N, Babu G, Greenland M, Kelly S, Ireen M, Islam K, O'Reilly P, Scherrer KS, Pitzer VE, Neuzil KM, Zaman K, Pollard AJ, Clemens JD. Qadri F, et al. Lancet. 2021 Aug 21;398(10301):675-684. doi: 10.1016/S0140-6736(21)01124-7. Epub 2021 Aug 9. Lancet. 2021. PMID: 34384540 Free PMC article. Clinical Trial.
Effect of a Sedation and Ventilator Liberation Protocol vs Usual Care on Duration of Invasive Mechanical Ventilation in Pediatric Intensive Care Units: A Randomized Clinical Trial.
Blackwood B, Tume LN, Morris KP, Clarke M, McDowell C, Hemming K, Peters MJ, McIlmurray L, Jordan J, Agus A, Murray M, Parslow R, Walsh TS, Macrae D, Easter C, Feltbower RG, McAuley DF; SANDWICH Collaborators. Blackwood B, et al. JAMA. 2021 Aug 3;326(5):401-410. doi: 10.1001/jama.2021.10296. JAMA. 2021. PMID: 34342620 Free PMC article. Clinical Trial.
IMPORTANCE: There is limited evidence on the optimal strategy for liberating infants and children from invasive mechanical ventilation in the pediatric intensive care unit. ...DESIGN, SETTING, AND PARTICIPANTS: A pragmatic multicenter, stepped-wedge, cluster …
IMPORTANCE: There is limited evidence on the optimal strategy for liberating infants and children from invasive mechanical ventilatio …
Comparison of three intraosseous access devices for resuscitation of term neonates: a randomised simulation study.
Keller A, Boukai A, Feldman O, Diamand R, Shavit I. Keller A, et al. Arch Dis Child Fetal Neonatal Ed. 2022 May;107(3):289-292. doi: 10.1136/archdischild-2021-321988. Epub 2021 Aug 2. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34340986 Clinical Trial.
OBJECTIVES: To compare the success rates and ease of use of three intraosseous (IO) access devices used in term neonates. DESIGN: A three-arm randomised controlled simulation study was conducted. ...CONCLUSIONS: Although easier to use, the EZ-IO drill demonstrated lower su …
OBJECTIVES: To compare the success rates and ease of use of three intraosseous (IO) access devices used in term neonates. DESIGN: A t …
Assessment of optimal chest compression depth during neonatal cardiopulmonary resuscitation: a randomised controlled animal trial.
Bruckner M, Kim SY, Shim GH, Neset M, Garcia-Hidalgo C, Lee TF, O'Reilly M, Cheung PY, Schmölzer GM. Bruckner M, et al. Arch Dis Child Fetal Neonatal Ed. 2022 May;107(3):262-268. doi: 10.1136/archdischild-2021-321860. Epub 2021 Jul 30. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34330756 Clinical Trial.
AIM: The study aimed to examine the optimal anterior-posterior depth which will reduce the time to return of spontaneous circulation and improve survival during chest compressions. Asphyxiated neonatal piglets receiving chest compression resuscitated with a 40% anterior-po …
AIM: The study aimed to examine the optimal anterior-posterior depth which will reduce the time to return of spontaneous circulation and imp …
Patient Portal Reminders for Pediatric Influenza Vaccinations: A Randomized Clinical Trial.
Lerner C, Albertin C, Casillas A, Duru OK, Ong MK, Vangala S, Humiston S, Evans S, Sloyan M, Fox CR, Bogard JE, Friedman S, Szilagyi PG. Lerner C, et al. Pediatrics. 2021 Aug;148(2):e2020048413. doi: 10.1542/peds.2020-048413. Pediatrics. 2021. PMID: 34321338 Free PMC article. Clinical Trial.
METHODS: We conducted an intention-to-treat randomized clinical trial of 22 046 children from 6 months to <18 years of age in 53 primary care practices. Patients (or parent and/or proxies) who were active portal users were randomly assigned to receive reminder messages …
METHODS: We conducted an intention-to-treat randomized clinical trial of 22 046 children from 6 months to <18 years of age in 53 primary …
Effect of Early Feeding on Intestinal Permeability and Inflammation Markers in Infants with Genetic Susceptibility to Type 1 Diabetes: A Randomized Clinical Trial.
Siljander H, Jason E, Ruohtula T, Selvenius J, Koivusaari K, Salonen M, Ahonen S, Honkanen J, Ilonen J, Vaarala O, Virtanen SM, Lähdeaho ML, Knip M. Siljander H, et al. J Pediatr. 2021 Nov;238:305-311.e3. doi: 10.1016/j.jpeds.2021.07.042. Epub 2021 Jul 20. J Pediatr. 2021. PMID: 34293372 Free article. Clinical Trial.
OBJECTIVES: To assess whether weaning to an extensively hydrolyzed formula (EHF) decreases gut permeability and/or markers of intestinal inflammation in infants with HLA-conferred diabetes susceptibility, when compared with conventional formula. ...After further parental c …
OBJECTIVES: To assess whether weaning to an extensively hydrolyzed formula (EHF) decreases gut permeability and/or markers of intestinal inf …
Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial.
Heo JS, Kim EK, Kim SY, Song IG, Yoon YM, Cho H, Lee ES, Shin SH, Oh BM, Shin HI, Kim HS. Heo JS, et al. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):166-173. doi: 10.1136/archdischild-2021-321945. Epub 2021 Jul 19. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34281934 Clinical Trial.
SETTING: Neonatal intensive care unit of a South Korean tertiary hospital. PARTICIPANTS: Preterm infants born at <32 weeks of gestation who achieved full tube feeding. ...CONCLUSIONS: In very preterm infants, DST+OSMS led to the …
SETTING: Neonatal intensive care unit of a South Korean tertiary hospital. PARTICIPANTS: Preterm infants
Cost-Effectiveness of Nasal High Flow Versus CPAP for Newborn Infants in Special-Care Nurseries.
Huang L, Manley BJ, Arnolda GRB, Owen LS, Wright IMR, Foster JP, Davis PG, Buckmaster AG, Dalziel KM. Huang L, et al. Pediatrics. 2021 Aug;148(2):e2020020438. doi: 10.1542/peds.2020-020438. Epub 2021 Jul 16. Pediatrics. 2021. PMID: 34272343 Clinical Trial.
BACKGROUND: Treating respiratory distress in newborns is expensive. We compared the cost-effectiveness of 2 common noninvasive therapies, nasal continuous positive airway pressure (CPAP) and nasal high-flow (nHF), for newborn infants cared for in nontertiary …
BACKGROUND: Treating respiratory distress in newborns is expensive. We compared the cost-effectiveness of 2 common noninvasive therap …
Comparison of volume guarantee and volume-controlled ventilation both using closed loop inspired oxygen in preterm infants: a randomised crossover study (CLIO-VG study).
Nair V, Lal MK, Gillone J, Kannan Loganathan P, Bachman TE. Nair V, et al. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):161-165. doi: 10.1136/archdischild-2021-321712. Epub 2021 Jul 7. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34233907 Clinical Trial.
OBJECTIVE: The objective of this study was to compare two different modes of ventilation in maintaining oxygen saturation (SpO2) in target range (90%-95%) in ventilated preterm infants cared for with automatic control of oxygen delivery (A-FiO2). DESIGN: A single-ce …
OBJECTIVE: The objective of this study was to compare two different modes of ventilation in maintaining oxygen saturation (SpO2) in target r …
Intracranial Hemorrhage and 2-Year Neurodevelopmental Outcomes in Infants Born Extremely Preterm.
Law JB, Wood TR, Gogcu S, Comstock BA, Dighe M, Perez K, Puia-Dumitrescu M, Mayock DE, Heagerty PJ, Juul SE. Law JB, et al. J Pediatr. 2021 Nov;238:124-134.e10. doi: 10.1016/j.jpeds.2021.06.071. Epub 2021 Jul 2. J Pediatr. 2021. PMID: 34217769 Free PMC article. Clinical Trial.
STUDY DESIGN: Infants enrolled in the Preterm Erythropoietin Neuroprotection Trial had serial cranial ultrasound scans performed on day 1, day 7-9, and 36 weeks of postmenstrual age to evaluate ICH. ...Bilateral and increasing grade of ICH were associated with death …
STUDY DESIGN: Infants enrolled in the Preterm Erythropoietin Neuroprotection Trial had serial cranial ultrasound scans perform …
Growth Rates of Infants Randomized to Continuous Positive Airway Pressure or Intubation After Extremely Preterm Birth.
Salas AA, Carlo WA, Do BT, Bell EF, Das A, Van Meurs KP, Poindexter BB, Shankaran S, Younge N, Watterberg KL, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Salas AA, et al. J Pediatr. 2021 Oct;237:148-153.e3. doi: 10.1016/j.jpeds.2021.06.026. Epub 2021 Jun 19. J Pediatr. 2021. PMID: 34157349 Free PMC article. Clinical Trial.
OBJECTIVE: To evaluate the effects of early treatment with continuous positive airway pressure (CPAP) on nutritional intake and in-hospital growth rates of extremely preterm (EPT) infants. STUDY DESIGN: EPT infants (24(0/7)-27(6/7) weeks of gestation) enrolle …
OBJECTIVE: To evaluate the effects of early treatment with continuous positive airway pressure (CPAP) on nutritional intake and in-hospital …
Family integrated care: very preterm neurodevelopmental outcomes at 18 months.
Synnes AR, Petrie J, Grunau RE, Church P, Kelly E, Moddemann D, Ye X, Lee SK, O'Brien K; Canadian Neonatal Network Investigators; Canadian Neonatal Follow-Up Network Investigators. Synnes AR, et al. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):76-81. doi: 10.1136/archdischild-2020-321055. Epub 2021 Jun 18. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34145042 Clinical Trial.
OBJECTIVE: To examine whether the family integrated care (FICare) programme, a multifaceted approach which enables parents to be engaged as primary caregivers in the neonatal intensive care unit, impacts infant neurodevelopment and growth at 18 …
OBJECTIVE: To examine whether the family integrated care (FICare) programme, a multifaceted approach which enables parents to be enga …
Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial.
Salverda HH, Cramer SJE, Witlox RSGM, Gale TJ, Dargaville PA, Pauws SC, Te Pas AB. Salverda HH, et al. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):20-25. doi: 10.1136/archdischild-2020-321387. Epub 2021 Jun 10. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34112721 Free PMC article. Clinical Trial.
DESIGN: Randomised cross-over study. SETTING: Tertiary level neonatal unit in the Netherlands. PATIENTS: Preterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO(2) …
DESIGN: Randomised cross-over study. SETTING: Tertiary level neonatal unit in the Netherlands. PATIENTS: Preterm infants
Prediction of outcome from MRI and general movements assessment after hypoxic-ischaemic encephalopathy in low-income and middle-income countries: data from a randomised controlled trial.
Aker K, Thomas N, Adde L, Koshy B, Martinez-Biarge M, Nakken I, Padankatti CS, Støen R. Aker K, et al. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):32-38. doi: 10.1136/archdischild-2020-321309. Epub 2021 Jun 10. Arch Dis Child Fetal Neonatal Ed. 2022. PMID: 34112719 Free PMC article. Clinical Trial.
OBJECTIVE: To evaluate the accuracy of neonatal MRI and general movements assessment (GMA) in predicting neurodevelopmental outcomes in infants with hypoxic-ischaemic encephalopathy (HIE). DESIGN: Secondary analyses of a randomised controlled trial (RCT). SETTING: T …
OBJECTIVE: To evaluate the accuracy of neonatal MRI and general movements assessment (GMA) in predicting neurodevelopmental outcomes …
Aqueous chlorhexidine 1% versus 2% for neonatal skin antisepsis: a randomised non-inferiority trial.
Sharma A, Kulkarni S, Thukral A, Sankar MJ, Agarwal R, Deorari AK, Mohapatra S, Velpandian T, Bajpai M. Sharma A, et al. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):643-648. doi: 10.1136/archdischild-2020-321174. Epub 2021 Jun 9. Arch Dis Child Fetal Neonatal Ed. 2021. PMID: 34108192 Free PMC article. Clinical Trial.
OBJECTIVE: To evaluate whether 1% aqueous chlorhexidine gluconate (CHG) when compared with 2% aqueous chlorhexidine gluconate is non-inferior for neonatal skin antisepsis. DESIGN: Parallel, blinded, non-inferiority randomised trial. SETTING: Level III, academic, neonata
OBJECTIVE: To evaluate whether 1% aqueous chlorhexidine gluconate (CHG) when compared with 2% aqueous chlorhexidine gluconate is non-inferio …
Meningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlers.
Tapia MD, Sow SO, Naficy A, Diallo F, Haidara FC, Chaudhari A, Martellet L, Traore A, Townsend-Payne K, Borrow R, Hosken N, Smolenov I, Pisal SS, LaForce FM, Dhere RM, Kapse D, Tang Y, Alderson MR, Kulkarni PS. Tapia MD, et al. N Engl J Med. 2021 Jun 3;384(22):2115-2123. doi: 10.1056/NEJMoa2013615. N Engl J Med. 2021. PMID: 34077644 Clinical Trial.