Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

Completed · Not applicable

Conditions studied: Necrotizing Enterocolitis

In brief

The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.

Key facts

Study ID

NCT00252681

Run by

Yale University

People needed

130

Starts

1999-07-01

Expected to finish

2005-06-01

Last updated by the study team

2006-07-21

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birth weight less than 1500 grams
• Gestational age 24 -33 weeks
• Diagnosed with necrotizing enterocolitis based on Bell stage II or greater
• Bowel perforation as evidenced by free intraperitoneal air seen on abdominal radiograph, stool, bile, or pus found at paracentesis or clinical evidence of perforation in the joint opinion of the attending surgeon and neonatologist.

You may not qualify if…

• Bilateral Grade IV intraventricular hemorrhage
• Previous abdominal surgery
• Evidence of gastrointestinal anomaly (i.e. atresia, malrotation etc.)

Where it is running

• Yale University School of Medicine Section of Pediatric Surgery — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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