Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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.

Official Title

A Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for ELBW Infants With Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP): Outcomes at 18-22 Months Adjusted Age

Eligibility Criteria

Ages Eligible for Study: Younger than 8 Weeks
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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


Karl G. Sylvester
Karl G. Sylvester
Professor of Surgery (Pediatric Surgery)
David K. Stevenson, M.D.

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M. Bethany Ball