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Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
This study is ongoing, but not recruiting participants.
Study NCT00033917   Information provided by Yale University
First Received: April 12, 2002   Last Updated: June 12, 2009   History of Changes

April 12, 2002
June 12, 2009
September 1989
 
IVH [ Time Frame: at 16 years ] [ Designated as safety issue: No ]
behavioral and cognitive follow-up assessments using the Peabody Picture Vocabulary Test-Revised and Wechsler intelligence scales [ Time Frame: at the ages of 3, 4 1/2, 6 and 8 ]
Complete list of historical versions of study NCT00033917 on ClinicalTrials.gov Archive Site
neurodevelopmental outcome, volumetric MRI, diffusion tensor MRI, functional MRI [ Time Frame: at 16 years ] [ Designated as safety issue: No ]
Same as current
 
Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
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 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.

Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
  • Intraventricular Hemorrhage (IVH)
  • Bleeding in the Brain
  • Prematurity
  • Very Low Birth Weight Infants
  • Drug: indomethacin
  • Other: placebo
  • Active Comparator: indomethacin
  • Placebo Comparator: placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
630
March 2010
 
  • Preterm infants < 1250 g birth weight
  • Admitted to participating institution < 6 hrs of age
  • No evidence for congenital malformations
  • Cranial US at 6 postnatal hours without evidence of Grades III - IV intraventricular hemorrhage
Both
up to 6 Hours
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033917
Laura R. Ment, M.D., Professor, Departments of Pediatrics and Neurology, Yale University School of Medicine
R01NS27116
Yale University
 
Principal Investigator: Laura R. Ment, M.D. Department of Pediatrics, Yale University School of Medicine
Yale University
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP