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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Page 1 of 5 (17 locations)

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