Trial record 4 of 29 for:    necrotizing enterocolitis | NIH

Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00252681
First received: November 9, 2005
Last updated: July 20, 2006
Last verified: November 2005
  Purpose

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


Condition Intervention
Necrotizing Enterocolitis
Procedure: laparotomy
Procedure: primary peritoneal drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • The primary outcome variable is operative mortality, i.e. death within 90 days of intervention.

Secondary Outcome Measures:
  • The secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.

Estimated Enrollment: 130
Study Start Date: July 1999
Estimated Study Completion Date: June 2005
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 A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252681

Locations
United States, Connecticut
Yale University School of Medicine Section of Pediatric Surgery
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: R. Lawrence Moss, MD Yale University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00252681     History of Changes
Other Study ID Numbers: RO1 HD38462, Gen Clin Res Ctr #M01-RR00125
Study First Received: November 9, 2005
Last Updated: July 20, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
randomized
controlled
trial
necrotizing
enterocolitis
premature
infants
laparotomy
peritoneal
drainage

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 23, 2014