Necrotizing Enterocolitis (NEC) Surgical Database

January 14, 2008 updated by: Boston Children's Hospital

GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital, Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Yale University
Elizabeth Glaser Pediatric AIDS Foundation
Glaser Pediatric Research Network

Investigators

  • Principal Investigator: Tom Jaskic, MPH, PhD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

July 7, 2005

First Posted (ESTIMATE)

July 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 14, 2008

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X03-12-080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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