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NCT00059449 Clinical Trial

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

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00059449
Other study ID # EGFDNE (completed)
Secondary ID
Status Completed
Phase N/A
First received April 25, 2003
Last updated January 12, 2010

Study information
Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 372
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 72 Hours
Eligibility Inclusion Criteria:

- Gestational Age greater than 23 weeks at birth

- Birth weight greater than 500 grams

- Age less than 72 hours of life

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Good Samaritan Hospital Cincinnati Ohio
United States University Hospital Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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