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

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

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment

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.

Intervention(s) in this Clinical Trial

• Drug: indomethacin
  • an anti-inflammatory drug
• Other: placebo
  • an inactive substance

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • indomethacin
• Placebo Comparator: 2
  • placebo

Primary Measures

• IVH
  • Time Frame: at 16 years
    Safety Issue?: No

Secondary Measures

• neurodevelopmental outcome, volumetric MRI, diffusion tensor MRI, functional MRI
  • Time Frame: at 16 years
    Safety Issue?: No

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 6 Hours

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00033917

Study ID Number: R01NS27116

ClinicalTrials.gov Identifier: NCT00033917

Health Authority: United States: Federal Government