Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

Yale University

Status

Completed

Conditions

Necrotizing Enterocolitis

Treatments

Procedure: primary peritoneal drainage

Procedure: laparotomy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00252681

Gen Clin Res Ctr #M01-RR00125

R01HD038462

Details and patient eligibility

About

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

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 A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an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

Sex

All

Ages

Under 3 months old

Volunteers

No Healthy Volunteers

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