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

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

This study is ongoing, but not recruiting participants.

Study NCT00033917. Last updated on December 5, 2007. Information provided by National Institute of Neurological Disorders and Stroke (NINDS)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

IVH [ Time Frame: at 16 years ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

neurodevelopmental outcome, volumetric MRI, diffusion tensor MRI, functional MRI [ Time Frame: at 16 years ] [ Designated as safety issue: No ]

Condition ^†

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

Intervention ^†

Drug: indomethacin
Other: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

630

Start Date ^†

September 1989

Completion Date

March 2010

Eligibility 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

Gender

Both

Ages

up to 6 Hours

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00033917

Organization ID

R01NS27116

Secondary IDs ^††

Study Sponsor ^†

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators ^††

Investigators ^†

Principal Investigator:

Laura R. Ment, M.D.

Department of Pediatrics, Yale University School of Medicine

Information Provided By

National Institute of Neurological Disorders and Stroke (NINDS)

Verification Date

December 2007

First Received Date ^†

April 12, 2002

Last Updated Date

December 5, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.