NCT00120159

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 15, 2005

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2006

First QC Date

June 30, 2005

Last Update Submit

January 14, 2008

Conditions

Necrotizing Enterocolitis

Keywords

Necrotizing Enterocolitis

Eligibility Criteria

Age1 Day - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Tom Jaskic, MPH, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 15, 2005

Study Start

December 1, 2003

Last Updated

January 15, 2008

Record last verified: 2006-01

Locations

US(1)