Feasibility and acceptability of a diagnostic randomized clinical trial of bowel ultrasound in infants with suspected necrotizing enterocolitis

Eur J Pediatr. 2022 Aug;181(8):3211-3215. doi: 10.1007/s00431-022-04526-4. Epub 2022 Jun 17.


We conducted a pilot diagnostic randomized clinical trial (RCT) to examine the feasibility, acceptability, and preliminary outcomes of adding bowel ultrasound (BUS) to the diagnostic evaluation for necrotizing enterocolitis (NEC). Infants ≤ 32 weeks' gestational age with NEC concern were randomized to undergo abdominal X-ray (AXR) or AXR + BUS. The primary outcome was study feasibility. Secondary outcomes included rates of NEC diagnosis and duration of treatment with bowel rest and antibiotics. A total of 56 infants were enrolled; 16 developed NEC concern and were randomized. Rates of recruitment (56/82 = 68%), retention (16/16 = 100%), and protocol compliance (126/127 = 99%) met pre-specified thresholds for feasibility. No significant differences in rates of NEC diagnosis were found between the two groups. Durations of bowel rest and antibiotic treatment were also similar. Conclusion: Our study supports the feasibility of conducting a definitive diagnostic RCT to establish safety and efficacy of BUS for NEC. Clinical trial registration: The study was registered at https://clinicaltrials.gov (NCT03963011). What is Known: • Bowel ultrasound (BUS) is increasingly being utilized as an adjunct to abdominal radiographs in evaluating for necrotizing enterocolitis (NEC). • The impact of BUS on patient outcomes is unknown. What is New: • A diagnostic randomized controlled trial study design to determine safety and effectiveness of adding BUS to NEC evaluation is feasible and acceptable.

Keywords: Clinical trial; Necrotizing enterocolitis; Prematurity; Sonography; Ultrasound.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Enterocolitis, Necrotizing* / diagnostic imaging
  • Enterocolitis, Necrotizing* / drug therapy
  • Feasibility Studies
  • Gestational Age
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Newborn, Diseases*
  • Ultrasonography

Associated data

  • ClinicalTrials.gov/NCT03963011