Clinical Trial: Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial

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 Summary:

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 A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate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.

Sponsor: Yale University

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

Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.

Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: November 9, 2005
Date Started: July 1999
Date Completion: June 2005
Last Updated: July 20, 2006
Last Verified: November 2005