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Necrotizing Enterocolitis (NEC) Surgical Database

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ClinicalTrials.gov Identifier: NCT00120159
Recruitment Status : Unknown
Verified January 2006 by Boston Children’s Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2005
Last Update Posted : January 15, 2008
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Yale University
Information provided by:
Boston Children’s Hospital

Brief Summary:
The general objectives of this protocol are to develop a multi-center prospective data collection process to identify risk factors for progression of Necrotizing Enterocolitis (NEC). These data will be used as a basis for identifying management strategies appropriate for further evaluation (randomized controlled trials), to develop evidence-based standards of care, and as a tool to facilitate quality-assessment at individual centers through comparison of outcomes with the entire database.

Condition or disease
Necrotizing Enterocolitis

Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Retrospective
Official Title: GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol
Study Start Date : December 2003

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients must meet at least one criterion from each of the following three categories:

Historical Factors:

  • Feeding intolerance defined as vomiting of 2 or more feedings within 24 hours or any vomitus containing bile, or the presence of gastric residuals of volume greater than 6cc/kg or any aspirate containing bile
  • Apneic/bradycardic episodes
  • Oxygen desaturation episode not otherwise explained
  • Guaiac positive or grossly bloody stools

Physical Examination Findings:

  • Abdominal distention recorded by practitioner
  • Capillary refill time greater than 2 seconds
  • Abdominal wall discoloration
  • Abdominal tenderness

Radiographic Findings:

  • Pneumatosis intestinalis
  • Portal venous gas
  • Ileus
  • Dilated bowel
  • Pneumoperitoneum
  • Air/fluid levels
  • Thickened bowel walls
  • Ascites or peritoneal fluid
  • Free intraperitoneal air

Exclusion Criteria:

Patients will be excluded for any of the following:

  • Major gastrointestinal anomaly
  • Prior abdominal operation
  • Family does not consent to participate (A list of patients for whom consent was refused will be maintained in order to avoid contacting these families repeatedly. All families who refuse consent will be queried as to the reason for refusal).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120159

United States, Massachusetts
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Yale University
Principal Investigator: Tom Jaskic, MPH, PhD Boston Children’s Hospital

ClinicalTrials.gov Identifier: NCT00120159     History of Changes
Other Study ID Numbers: X03-12-080
First Posted: July 15, 2005    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2006

Keywords provided by Boston Children’s Hospital:
Necrotizing Enterocolitis

Additional relevant MeSH terms:
Enterocolitis, Necrotizing
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases