Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

Not Applicable

Completed

• Conditions: Necrotizing Enterocolitis

• Registration Number: NCT00252681
• Lead Sponsor: Yale University

Brief Summary

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

Detailed Description

This is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage for perforated Necrotizing Enterocolitis. The current literature does not allow an objective comparison between these two methods. A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate determination as to the best treatment. The conclusion that only a randomized clinical trial would answer this question has led to this multi-center effort. The relative infrequency of the disease at any one neonatal center has necessitated enrollment of patients at many centers.

Comparison: Premature neonates weighing less than 1500 grams at birth who develop perforated necrotizing enterocolitis are randomized within two birth weight blocks (\<1000 gms and 1000 - 1499 gms) for treatment with either laparotomy or primary peritoneal drainage. Daily postoperative clinical care is kept uniform between the two groups by means of a critical care pathway. The primary outcome variable is mortality, i.e. death within 90 days of intervention. The main secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.

Study Timeline

• Study Start: 1999-07
• Study Completion: 2005-06
• Status Verified: 2005-11
• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-09
• Study First Posted: 2005-11-11
• Last Update Submitted: 2006-07-20
• Last Update Posted: 2006-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.

Trial Locations

Locations (1)

Yale University School of Medicine Section of Pediatric Surgery; 🇺🇸 New Haven, Connecticut, United States