NCT00059449

Brief Summary

Necrotizing enterocolitis (NEC) is a serious gastrointestinal disorder that primarily affects preterm infants. About 10% of babies less than 32 weeks gestation at birth will develop it. Overall, 30% of babies who develop NEC will die from it, with many others developing long term gastrointestinal problems. The most important factor in its development is a premature intestinal tract. Epidermal growth factor (EGF) is an important growth factor in the development and maintenance of the gastrointestinal tract. This study will look for a relationship between EGF levels in premature babies and the development of NEC.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
372

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2003

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

First QC Date

April 25, 2003

Last Update Submit

January 12, 2010

Conditions

Necrotizing EnterocolitisPremature Birth

Keywords

Enterocolitis

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational Age greater than 23 weeks at birth
  • Birth weight greater than 500 grams
  • Age less than 72 hours of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University Hospital

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Enterocolitis, NecrotizingPremature BirthEnterocolitis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

April 25, 2003

First Posted

April 29, 2003

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

US(3)