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

Tracking Information
First Received Date ^ICMJE	April 25, 2003
Last Updated Date	November 15, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00059449 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis
Official Title ^ICMJE	Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis
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.
Detailed Description
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Prospective
Condition ^ICMJE	Necrotizing Enterocolitis Premature Birth
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	372
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Gestational Age greater than 23 weeks at birth Birth weight greater than 500 grams Age less than 72 hours of life
Gender	Both
Ages	up to 72 Hours
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00059449
Responsible Party
Study ID Numbers ^ICMJE	EGFDNE
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	November 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP