Status:
COMPLETED
Observational Study of Surgical Treatment of Necrotizing Enterocolotis
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
Up to 6 years
Brief Summary
The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enteroc...
Detailed Description
Necrotizing enterocolitis (NEC) is a condition, generally affecting premature infants, in which the intestines become ischemic (lack oxygen and/or blood flow). NEC occurs in up to 5-15% of extremely l...
Eligibility Criteria
Inclusion
- Infants born 401-1,000 grams at birth enrolled in the NRN Generic Database
- Sage III NEC or isolated intestinal perforation
- Pediatric surgeon decision to perform surgery for suspected NEC or IP
Exclusion
- Decision not to treat
Key Trial Info
Start Date :
March 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01223261
Start Date
March 1 2001
End Date
March 1 2004
Last Update
March 22 2019
Active Locations (17)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
University of California at San Diego
San Diego, California, United States, 92103-8774
4
Yale University
New Haven, Connecticut, United States, 06504