Trial ID or NCT#

NCT01029353

Status

NOT RECRUITING

Purpose

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

Investigator(s)

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

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CONTACT

M. Bethany Ball
(650) 725-8342