Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intraventricular Hemorrhage (IVH); Bleeding in the Brain; Prematurity; Very Low Birth Weight Infants
Intervention: indomethacin (Drug); placebo (Other)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS) Official(s) and/or principal investigator(s):
Laura R. Ment, M.D., Principal Investigator, Affiliation: Department of Pediatrics, Yale University School of Medicine
Summary
The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in
the brain of very low birth weight preterm infants.
Clinical Details
Official title: Randomized Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Primary outcome: IVH
Secondary outcome: neurodevelopmental outcome, volumetric MRI, diffusion tensor MRI, functional MRI
Detailed description:
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, and 125 term
infant controls. 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
Minimum age: N/A.
Maximum age: 6 Hours.
Gender(s): Both.
Criteria:
- Preterm infants < 1250 g birth weight
- Admitted to participating institution < 6 hrs of age
- No evidence for congenital malformations
- Cranial US at 6 postnatal hours without evidence of Grades III - IV intraventricular
hemorrhage
Locations and Contacts
Yale University School of Medicine, New Haven, Connecticut, United States
Maine Medical Center, Portland, Michigan, United States
Brown University School of Medicine, Providence, Rhode Island, United States
Additional Information
Starting date: September 1989
Ending date: March 2010
Last updated: December 5, 2007
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