Observational Study of Surgical Treatment of Necrotizing Enterocolotis

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 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.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Enterocolitis, Necrotizing
• Intestinal Perforation

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Martin L. Blakely, MD · The University of Texas Health Science Center, Houston

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• William Oh, MD · Brown University, Women & Infants Hospital of Rhode Island

• Avroy A. Fanaroff, MD · Case Western Reserve University, Rainbow Babies & Children's Hospital

• Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

• Barbara J. Stoll, MD · Emory University

• Charles R. Bauer, MD · University of Miami

• James A. Lemons, MD · Indiana University

• David K. Stevenson, MD · Stanford University

• Abbot R. Laptook, MD · University of Texas

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• Ronald N. Goldberg, MD · Duke University

• T. Michael O'Shea, MD MPH · Wake Forest University

• Dale L. Phelps, MD · University of Rochester

• Neil N. Finer, MD · University of California, San Diego

• W. Kenneth Poole, PhD · RTI International

Eligibility

Max Age

6 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-03-31

Primary Completion

2002-09-30

Completion

2004-03-31

Countries

• United States

Study Locations