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Randomized Controlled Trial
. 2016 Aug 18;17:414.
doi: 10.1186/s13063-016-1498-7.

Efficacy of a New Technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - In Preterm Neonates With Respiratory Distress Syndrome: Study Protocol for a Randomized Controlled Trial

Giovanni Vento  1 Roberta Pastorino  2 Luca Boni  3 Francesco Cota  4 Virgilio Carnielli  5 Filip Cools  6 Carlo Dani  7 Fabio Mosca  8 Jane Pillow  9 Graeme Polglase  10 Paolo Tagliabue  11 Anton H van Kaam  12 Maria Luisa Ventura  11 Milena Tana  4 Chiara Tirone  4 Claudia Aurilia  4 Alessandra Lio  4 Cinzia Ricci  4 Alessandro Gambacorta  4 Chiara Consigli  13 Danila D'Onofrio  13 Camilla Gizzi  14 Luca Massenzi  14 Viviana Cardilli  15 Alessandra Casati  16 Roberto Bottino  17 Federica Pontiggia  17 Elena Ciarmoli  11 Stefano Martinelli  18 Laura Ilardi  18 Mariarosa Colnaghi  8 Piero Giuseppe Matassa  8 Valentina Vendettuoli  8 Paolo Villani  19 Francesca Fusco  19 Diego Gazzolo  20 Alberto Ricotti  20 Federica Ferrero  21 Ilaria Stasi  21 Rosario Magaldi  22 Gianfranco Maffei  22 Giuseppe Presta  23 Roberto Perniola  23 Francesco Messina  24 Giovanna Montesano  24 Chiara Poggi  25 Lucio Giordano  26 Enza Roma  26 Carolina Grassia  27 Gaetano Ausanio  27 Fabrizio Sandri  28 Giovanna Mescoli  28 Francesco Giura  28 Giampaolo Garani  29 Agostina Solinas  29 Maria Lucente  30 Gabriella Nigro  30 Antonello Del Vecchio  31 Flavia Petrillo  31 Luigi Orfeo  32 Lidia Grappone  32 Lorenzo Quartulli  33 Antonio Scorrano  33 Hubert Messner  34 Alex Staffler  34 Giancarlo Gargano  35 Eleonora Balestri  35 Stefano Nobile  36 Caterina Cacace  37 Valerio Meli  37 Sara Dallaglio  38 Betta Pasqua  39 Loretta Mattia  39 Eloisa Gitto  40 Marcello Vitaliti  41 Maria Paola Re  41 Stefania Vedovato  42 Alessandra Grison  42 Alberto Berardi  43 Francesco Torcetta  43 Isotta Guidotti  43 Sandra di Fabio  44 Eugenia Maranella  44 Isabella Mondello  45 Stefano Visentin  46 Francesca Tormena  46
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Free PMC article
Randomized Controlled Trial

Efficacy of a New Technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - In Preterm Neonates With Respiratory Distress Syndrome: Study Protocol for a Randomized Controlled Trial

Giovanni Vento et al. Trials. .
Free PMC article

Abstract

Background: Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an "optimal" functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria.

Methods/design: In this study, 206 spontaneously breathing infants born at 24(+0)-27(+6) weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation.

Discussion: From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment maneuver performed with a step-by-step Continuous Distending Pressure increase during High-Frequency Oscillatory Ventilation (and not with a sustained inflation) could have a positive effects in terms of improved surfactant distribution and consequent its major efficacy in preterm newborns with respiratory distress syndrome. This represents our challenge.

Trial registration: ClinicalTrials.gov identifier: NCT02482766 . Registered on 1 June 2015.

Keywords: HFOV; INSURE; Lung recruitment; Preterm infants.

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References

    1. Van Marter LJ, Allred EN, Pagano M, et al. Do clinical markers of barotrauma and oxygen toxicity explain interhospital variation in rates of chronic lung disease? The Neonatology Committee for the Developmental Network. Pediatrics. 2000;105:1194–201. doi: 10.1542/peds.105.6.1194. - DOI - PubMed
    1. Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB, COIN Trial Investigators Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008;358(7):700–8. doi: 10.1056/NEJMoa072788. - DOI - PubMed
    1. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010;362(21):1970–9. doi: 10.1056/NEJMoa0911783. - DOI - PMC - PubMed
    1. Dunn MS, Kaempf J, de Klerk A, de Klerk R, Reilly M, Howard D, Ferrelli K, O’Conor J, Soll RF, Vermont Oxford Network DRM Study Group Randomized trial comparing 3 approaches to the initial respiratory management of preterm neonates. Pediatrics. 2011;128(5):e1069–76. doi: 10.1542/peds.2010-3848. - DOI - PubMed
    1. Dargaville PA, Aiyappan A, De Paoli AG, Dalton RG, Kuschel CA, Kamlin CO, et al. Continuous positive airway pressure failure in preterm infants: incidence, predictors and consequences. Neonatology. 2013;104(1):8–14. doi: 10.1159/000346460. - DOI - PubMed

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