Trial Search Results

Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: National Center for Research Resources (NCRR)

Intervention(s):

  • Procedure: Laparotomy
  • Procedure: Drainage

Phase:

N/A

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

Ages Eligible for Study

N/A - 8 Weeks

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
M. Bethany Ball
6507258342
Not Recruiting