Observational Study of Surgical Treatment of Necrotizing Enterocolotis

Not Recruiting

Trial ID: NCT01223261


The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.

Official Title

Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation

Stanford Investigator(s)


Inclusion Criteria:

   - Infants born 401-1,000 grams at birth enrolled in the NRN Generic Database

   - Sage III NEC or isolated intestinal perforation

   - Pediatric surgeon decision to perform surgery for suspected NEC or IP

Exclusion Criteria:

   - Decision not to treat

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305