CompletedNot Applicable

Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

United States130 participantsStarted 1999-07

Plain-language summary

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

Who can participate

Age range0 Years – 3 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Bilateral Grade IV intraventricular hemorrhage * Previous abdominal surgery * Evidence of gastrointestinal anomaly (i.e. atresia, malrotation etc.)

What they're measuring

The primary outcome variable is operative mortality, i.e. death within 90 days of intervention.

Trial details

NCT IDNCT00252681

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

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