GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol

Boston Children's Hospital1 site in 1 country300 target enrollmentDecember 2003

ConditionsNecrotizing Enterocolitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Necrotizing Enterocolitis
Sponsor: Boston Children's Hospital
Enrollment: 300
Locations: 1
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

TBD

Last Updated

18 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boston Children's Hospital

Eligibility Criteria

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

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).