Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

Trial ID or NCT#

NCT01029353

Status

not recruiting iconNOT RECRUITING

Purpose

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

Investigator(s)

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

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

Contact

M. Bethany Ball
6507258342