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Home > "R" Clinical Trials Conditions > Randomized Indomethacin GMH/IVH Prevention Trial  Randomized Indomethacin GMH/IVH Prevention Trial
Randomized Indomethacin GMH/IVH Prevention Trial
For Condition: bleeding in the brain,intraventricular hemorrhage (IVH),prematurity,very low birth weight infants
Status: No longer recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.
Details: Intraventricular hemorrhage (IVH) or bleeding in the brain remains a major problem of preterm infants. This randomized, placebo-controlled multicenter trial enrolled 505 infants of 600 to 1250g birth weight to determine if indomethacin lowers the incidence of IVH. During this longitudinal trial, follow-up assessments have been performed at the ages of 3, 4 1/2, 6 and 8. The initial results at age 3 years revealed no advantages to the indomethacin group over and above the decreases in IVH, however, the results did show a significant increase in ventriculomegaly in the indomethacin negative or "placebo" group. Later results at 4 1/2 and 6 years of age showed beneficial effects of indomethacin on cognitive and behavioral outcomes over and above the effects on preventing IVH. The study investigators continue to followup with the children to find out if early use of indomethacin will continue to improve the outcomes of extremely low birth weight children.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Placebo Control
Minimum Age/Maximum Age: /6 Hours
Genders: Both
Protocol Entry Criteria: - Preterm infants < 1250 g birth weight; - Admitted to participating institution < 6 hrs of age; - No evidence for congenital malformations; and - Cranial US at 6 postnatal hours without evidence of Grades III - IV intraventricular hemorrhage
Total Enrollment: 505
Location and Contact Information:
Overall Study Official:
LauraMent, Principal Investigator, Department of Pediatrics, Yale University School of Medicine
Brown University School of Medicine
Providence, Rhode Island,
United States
Yale University School of Medicine
New Haven, Connecticut,
United States
Maine Medical Center
Portland, Michigan,
United States
Additional Information:
Study ID Numbers: R01NS27116;
Study Start Date: September 1989
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033917
Other Bleeding In The Brain Studies:
1. Randomized Indomethacin GMH/IVH Prevention Trial
Related Studies:
Other bleeding in the brain Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
Randomized Indomethacin GMH/IVH Prevention Trial
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