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

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00033917

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

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

Resource links provided by NLM:

Drug Information available for: Indomethacin

U.S. FDA Resources

Further study details as provided by Yale University:

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

Yale University

Investigators

Principal Investigator:

Laura R. Ment, M.D.

Department of Pediatrics, Yale University School of Medicine

More Information

No publications provided

Responsible Party:	Yale University School of Medicine ( Laura R. Ment, M.D., Professor, Departments of Pediatrics and Neurology )
Study ID Numbers:	R01NS27116
Study First Received:	April 12, 2002
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00033917 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Yale University:

intraventricular hemorrhage (IVH)
bleeding in the brain
indomethacin
prematurity
very low birth weight infants

Study placed in the following topic categories:

Birth Weight
Anti-Inflammatory Agents
Cerebral Hemorrhage
Cyclooxygenase Inhibitors
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Agents
Intracranial Hemorrhages
Hemorrhage
Brain Diseases

Cerebrovascular Disorders
Body Weight
Signs and Symptoms
Analgesics, Non-Narcotic
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Cerebral Hemorrhage
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Intracranial Hemorrhages
Reproductive Control Agents
Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Gout Suppressants
Body Weight
Signs and Symptoms
Pathologic Processes
Tocolytic Agents
Sensory System Agents

Therapeutic Uses
Indomethacin
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Birth Weight
Nervous System Diseases
Cyclooxygenase Inhibitors
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009