NCT00252681

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
Last Updated

July 21, 2006

Status Verified

November 1, 2005

First QC Date

November 9, 2005

Last Update Submit

July 20, 2006

Conditions

Necrotizing Enterocolitis

Keywords

randomizedcontrolledtrialnecrotizingenterocolitisprematureinfantslaparotomyperitonealdrainage

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

laparotomyPROCEDURE
primary peritoneal drainagePROCEDURE

Eligibility Criteria

Age0 Years - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine Section of Pediatric Surgery

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • 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.

    PMID: 16723614RESULT

MeSH Terms

Conditions

Enterocolitis, NecrotizingEnterocolitisPremature Birth

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • R. Lawrence Moss, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 11, 2005

Study Start

July 1, 1999

Study Completion

June 1, 2005

Last Updated

July 21, 2006

Record last verified: 2005-11

Locations

US(1)