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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00033917 |
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 |
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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 |
Enrollment: | 630 |
Study Start Date: | September 1989 |
Estimated Study Completion Date: | March 2010 |
Arms | Assigned Interventions |
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1: Active Comparator
indomethacin
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Drug: indomethacin
an anti-inflammatory drug
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2: Placebo Comparator
placebo
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Other: placebo
an inactive substance
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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.
Ages Eligible for Study: | up to 6 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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 |
Principal Investigator: | Laura R. Ment, M.D. | Department of Pediatrics, Yale University School of Medicine |
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: | December 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00033917 |
Health Authority: | United States: Federal Government |
intraventricular hemorrhage (IVH) bleeding in the brain indomethacin prematurity very low birth weight infants |
Body Weight Birth Weight Signs and Symptoms Cerebral Hemorrhage Indomethacin Vascular Diseases |
Central Nervous System Diseases Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases 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 Cardiovascular Diseases Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |