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Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

Primary Purpose

Necrotizing Enterocolitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
laparotomy
primary peritoneal drainage
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotizing Enterocolitis focused on measuring randomized, controlled, trial, necrotizing, enterocolitis, premature, infants, laparotomy, peritoneal, drainage

Eligibility Criteria

0 Years - 3 Months (Child)All SexesDoes not accept 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: Bilateral Grade IV intraventricular hemorrhage Previous abdominal surgery Evidence of gastrointestinal anomaly (i.e. atresia, malrotation etc.)

Sites / Locations

  • Yale University School of Medicine Section of Pediatric Surgery

Outcomes

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.

Full Information

First Posted
November 9, 2005
Last Updated
July 20, 2006
Sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00252681
Brief Title
Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants
Official Title
Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
Keywords
randomized, controlled, trial, necrotizing, enterocolitis, premature, infants, laparotomy, peritoneal, drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
laparotomy
Intervention Type
Procedure
Intervention Name(s)
primary peritoneal drainage
Primary Outcome Measure Information:
Title
The primary outcome variable is operative mortality, i.e. death within 90 days of intervention.
Secondary Outcome Measure Information:
Title
The secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Lawrence Moss, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine Section of Pediatric Surgery
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16723614
Citation
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. Erratum In: N Engl J Med. 2006 Aug 24;355(8):856.
Results Reference
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Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

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