CompletedNot Applicable

Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

United States529 participantsStarted 2010-01

Plain-language summary

This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival at 18-22 months corrected age.

Who can participate

Age range8 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants born at ≤1,000 g birth weight * Infant is ≤8 0/7 weeks of age at the time of eligibility assessment * Pediatric surgeon decision to perform surgery for suspected NEC or IP * Subject is at a center able to perform both laparotomy and drainage Exclusion Criteria: * Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations * Congenital infection * Prior laparotomy or peritoneal drain placement * Prior NEC or IP * Infant for whom full support is not being provided * Follow-up unlikely

What they're measuring

Death or Neurodevelopmental Impairment (NDI)

Timeframe: at 18-22 months corrected age

Trial details

NCT IDNCT01029353

SponsorNICHD Neonatal Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2019-08

Results submitted2020-09-02

View on ClinicalTrials.gov More Infant, Newborn trials