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

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 now accepting new patients for this trial. Please contact M. Bethany Ball at 6507258342 for more information.

Investigator(s):

Intervention(s):

  • procedure : laparotomy
  • procedure : Drainage

Phase: N/A

Eligibility

Ages Eligible For Study:

N/A - 8 Weeks

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

External Links

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Contact information

Primary Contact:

M. Bethany Ball 6507258342

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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