Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

Not Recruiting

Trial ID: NCT01029353

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

Stanford Investigator(s)

Karl G. Sylvester
Karl G. Sylvester

Professor of Surgery (Pediatric Surgery)

Eligibility

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

Intervention(s):

procedure: Drainage

procedure: laparotomy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
M. Bethany Ball
6507258342