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| 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. |
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| 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. |
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| 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 |
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| Intervention † | Drug: indomethacin Other: placebo |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 630 | ||||
| Start Date † | September 1989 | ||||
| Completion Date | March 2010 | ||||
| Eligibility Criteria † |
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| 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 † |
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| 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 | ||||