Status:
COMPLETED
Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants
Lead Sponsor:
Yale University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Conditions:
Necrotizing Enterocolitis
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.
Detailed Description
This is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage for perforated Necrotizing Enterocolitis. The current literature does not allow an objective comparison bet...
Eligibility Criteria
Inclusion
- Birth weight less than 1500 grams
- Gestational age 24 -33 weeks
- Diagnosed with necrotizing enterocolitis based on Bell stage II or greater
- Bowel perforation as evidenced by free intraperitoneal air seen on abdominal radiograph, stool, bile, or pus found at paracentesis or clinical evidence of perforation in the joint opinion of the attending surgeon and neonatologist.
Exclusion
- Bilateral Grade IV intraventricular hemorrhage
- Previous abdominal surgery
- Evidence of gastrointestinal anomaly (i.e. atresia, malrotation etc.)
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00252681
Start Date
July 1 1999
End Date
June 1 2005
Last Update
July 21 2006
Active Locations (1)
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1
Yale University School of Medicine Section of Pediatric Surgery
New Haven, Connecticut, United States, 06520