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

This study is no longer recruiting patients.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

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

Condition Treatment or Intervention Phase
intraventricular hemorrhage (IVH)
bleeding in the brain
prematurity
very low birth weight infants
 Drug: indomethacin
Phase III

MedlinePlus related topics:  Stroke

Study Type: Interventional
Study Design: Prevention, Randomized, Placebo Control

Official Title: Randomized Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrage (GMH/IVH) Prevention Trial

Further Study Details: 

Expected Total Enrollment:  505

Study start: September 1989

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

Ages Eligible for Study:  up to  6 Hours,  Genders Eligible for Study:  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

Location Information


Connecticut
      Yale University School of Medicine, New Haven,  Connecticut,  United States

Michigan
      Maine Medical Center, Portland,  Michigan,  United States

Rhode Island
      Brown University School of Medicine, Providence,  Rhode Island,  United States

Study chairs or principal investigators

Laura R. Ment, M.D.,  Principal Investigator,  Department of Pediatrics, Yale University School of Medicine   

More Information

Study ID Numbers:  R01NS27116
Record last reviewed:  October 2004
Last Updated:  October 14, 2004
Record first received:  April 12, 2002
ClinicalTrials.gov Identifier:  NCT00033917
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005