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

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	Intervention	Phase
Intraventricular Hemorrhage (IVH) Bleeding in the Brain Prematurity Very Low Birth Weight Infants	Drug: indomethacin Other: placebo	Phase III

ChemIDplus related topics:

Indomethacin

U.S. FDA Resources

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

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

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	630
Study Start Date:	September 1989
Estimated Study Completion Date:	March 2010

Arms	Assigned Interventions
1: Active Comparator indomethacin	Drug: indomethacin an anti-inflammatory drug
2: Placebo Comparator placebo	Other: placebo an inactive substance

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

Ages Eligible for Study:	up to 6 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033917

Locations


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

United States, Michigan
	Maine Medical Center
	Portland, Michigan, United States

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

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators


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

More Information

Responsible Party:	Yale University School of Medicine ( Laura R. Ment, M.D., Professor, Departments of Pediatrics and Neurology )
Study ID Numbers:	R01NS27116
First Received:	April 12, 2002
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00033917
Health Authority:	United States: Federal Government

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

intraventricular hemorrhage (IVH)

bleeding in the brain

indomethacin

prematurity

very low birth weight infants

Study placed in the following topic categories:

Body Weight

Birth Weight

Signs and Symptoms

Indomethacin

Hemorrhage

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Cardiovascular Agents

Reproductive Control Agents

Gout Suppressants

Pharmacologic Actions

Pathologic Processes

Tocolytic Agents

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents

Analgesics

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on July 18, 2008

Sponsored by:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:	NCT00033917