Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2005-06-30

Brief Summary

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

Detailed Description

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 A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an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

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Necrotizing Enterocolitis

Keywords

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randomized controlled trial necrotizing enterocolitis premature infants laparotomy peritoneal drainage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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laparotomy

Intervention Type PROCEDURE

primary peritoneal drainage

Intervention Type PROCEDURE

Eligibility Criteria

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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

* Bilateral Grade IV intraventricular hemorrhage
* Previous abdominal surgery
* Evidence of gastrointestinal anomaly (i.e. atresia, malrotation etc.)

Minimum Eligible Age

0 Years

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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R. Lawrence Moss, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University School of Medicine Section of Pediatric Surgery

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Moss RL, Dimmitt RA, Barnhart DC, Sylvester KG, Brown RL, Powell DM, Islam S, Langer JC, Sato TT, Brandt ML, Lee H, Blakely ML, Lazar EL, Hirschl RB, Kenney BD, Hackam DJ, Zelterman D, Silverman BL. Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation. N Engl J Med. 2006 May 25;354(21):2225-34. doi: 10.1056/NEJMoa054605.

Reference Type RESULT

PMID: 16723614 (View on PubMed)

Other Identifiers

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Gen Clin Res Ctr #M01-RR00125

Identifier Type: -

Identifier Source: secondary_id

R01HD038462

Identifier Type: NIH

Identifier Source: org_study_id

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