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Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial

NCT00033917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 630

Last updated 2013-03-28

Study results available
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Summary

The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.

Conditions

  • Intraventricular Hemorrhage (IVH)
  • Bleeding in the Brain
  • Prematurity
  • Very Low Birth Weight Infants

Interventions

DRUG

indomethacin

an anti-inflammatory drug

DRUG

placebo

saline

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Laura R. Ment, M.D. · Department of Pediatrics, Yale University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
6 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1989-09-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00033917 on ClinicalTrials.gov