Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033917
Status:
COMPLETED
Last Update Posted:
2013-03-28
First Post:
2002-04-12
Brief Title:
Indomethacin Germinal Matrix HemorrhageIntraventricular Hemorrhage GMHIVH Prevention Trial
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Randomized Indomethacin Germinal Matrix HemorrhageIntraventricular Hemorrhage GMHIVH Prevention Trial
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 12 6 8 12 and 16 years 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 placebo group Results at 4 12 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 At 12 and 16 years no significant influence of indomethacin on cognitive outcome was noted
Age gender and zip-code matched control subjects were added when the preterm subjects were 8 years Throughout all subsequent testing term controls have higher IQ and Peabody Picture Vocabulary Scores
Additional longitudinal volumetric functional and diffusion tensor MR imaging studies showed differences between preterm and term control subjects at 8 12 and 16 years of age These were consistent with utilization of the right hemisphere and left cerebellum for language in the preterm group compared to term controls No effects of indomethacin were seen
The study closed on 31 March 2012
Age gender and zip-code matched control subjects were added when the preterm subjects were 8 years Throughout all subsequent testing term controls have higher IQ and Peabody Picture Vocabulary Scores
Additional longitudinal volumetric functional and diffusion tensor MR imaging studies showed differences between preterm and term control subjects at 8 12 and 16 years of age These were consistent with utilization of the right hemisphere and left cerebellum for language in the preterm group compared to term controls No effects of indomethacin were seen
The study closed on 31 March 2012
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None