Necrotizing Enterocolitis Clinical Trial
Official title:
Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial
The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.
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and much unpublished data regarding the use of these procedures in the treatment of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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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