Trial ID or NCT#





This trial 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


Krisa Van Meurs
David K. Stevenson, M.D.
Susan R. Hintz, M.D., M.S. Epi.
Karl Sylvester
Professor of Surgery (Pediatric Surgery) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.


M. Bethany Ball
(650) 725-8342