Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

Not Recruiting

Trial ID: NCT01029353


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

Stanford Investigator(s)

Karl G. Sylvester
Karl G. Sylvester

Professor of Surgery (Pediatric Surgery)


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


procedure: Drainage

procedure: laparotomy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
M. Bethany Ball