NCT00252681

Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (planned)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 0 Years – 3 Months
• Healthy volunteers: Not accepted

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 A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an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

Conditions

• Necrotizing Enterocolitis

Interventions

Type	Name	Description
PROCEDURE	laparotomy
PROCEDURE	primary peritoneal drainage

Timeline

• Start date: 1999-07-01
• Completion: 2005-06-01
• First posted: 2005-11-11
• Last updated: 2006-07-21

Locations

1 site across 1 country: United States