Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants
Procedure: primary peritoneal drainage
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial|
- The primary outcome variable is operative mortality, i.e. death within 90 days of intervention.
- The secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.
|Study Start Date:||July 1999|
|Estimated Study Completion Date:||June 2005|
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 A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252681
|United States, Connecticut|
|Yale University School of Medicine Section of Pediatric Surgery|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||R. Lawrence Moss, MD||Yale University|