Prematurity Clinical Trial
Official title:
Randomized Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.
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, 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 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. 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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