Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis

This study has been completed.

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00059449

Purpose

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.

Condition
Necrotizing Enterocolitis Premature Birth

Drug Information available for: Epidermal Growth Factor

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:

372

Eligibility

Ages Eligible for Study:	up to 72 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059449

Locations

United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
University Hospital
Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

Study ID Numbers:	EGFDNE
Study First Received:	April 25, 2003
Last Updated:	November 15, 2007
ClinicalTrials.gov Identifier:	NCT00059449
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Enterocolitis

Study placed in the following topic categories:

Pregnancy Complications
Digestive System Diseases
Gastrointestinal Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Necrotizing enterocolitis

Intestinal Diseases
Gastroenteritis
Enterocolitis, Necrotizing
Enterocolitis
Premature Birth

ClinicalTrials.gov processed this record on January 16, 2009