Observational Study of Surgical Treatment of Necrotizing Enterocolotis

Completed

Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Enterocolitis, Necrotizing, Intestinal Perforation

In brief

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 enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.

Key facts

Study ID

NCT01223261

Run by

NICHD Neonatal Research Network

People needed

156

Starts

2001-03-01

Expected to finish

2004-03-01

Last updated by the study team

2019-03-22

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Decision not to treat

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• University of California at San Diego — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Wayne State University — Detroit, Michigan, United States
• University of Rochester — Rochester, New York, United States
• Wake Forest University — Charlotte, North Carolina, United States
• RTI International — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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