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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
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