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Clinical trialNCT01223261CompletedObservational

Observational Study of Surgical Treatment of Necrotizing Enterocolotis

SponsorNICHD Neonatal Research NetworkEnrollment156Enterocolitis, NecrotizingInfant, Low Birth WeightInfant, NewbornInfant, PrematureInfant, Small for Gestational AgeIntestinal Perforation
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

  • Duke University

    Durham, North Carolina, United States

  • Rti International

    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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2001
Primary completion
30 Sept 2002
Completion
31 Mar 2004
Last update posted
22 Mar 2019
Registered enrollment
156
Registry id
NCT01223261

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.