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| Sponsor: | Yale University |
|---|---|
| Information provided by (Responsible Party): | Laura R. Ment, 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: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
indomethacin
|
Drug: indomethacin
an anti-inflammatory drug
|
|
Placebo Comparator: 2
placebo
|
Other: placebo
an inactive substance
|
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, 6 and 8 years of age showed beneficial effects of indomethacin on cognitive and behavioral outcomes over and above the effects on preventing IVH but not at later ages. The study will close on March 31, 2012.
Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Contacts and Locations| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, 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 |
More Information
| Responsible Party: | Laura R. Ment, Professor Pediatrics and Neurology, Yale University |
| ClinicalTrials.gov Identifier: | NCT00033917 History of Changes |
| Other Study ID Numbers: | R01NS27116 |
| Study First Received: | April 12, 2002 |
| Last Updated: | January 25, 2012 |
| Health Authority: | United States: Federal Government |
|
intraventricular hemorrhage (IVH) bleeding in the brain indomethacin prematurity very low birth weight infants |
|
Birth Weight Hemorrhage Cerebral Hemorrhage Body Weight Signs and Symptoms Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Indomethacin Gout Suppressants |
Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents |
