Phase 3
N=431
Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
Intraventricular Hemorrhage (IVH) · Bleeding in the Brain · Prematurity · Very Low Birth Weight Infants
Bottom Line
View on ClinicalTrials.gov: NCT00033917 ↗Enrolled (actual)
431
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: IVH at 5 Postnatal Days — 25; 40 IVH
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- indomethacin (Drug); placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IVH at 5 Postnatal Days |
25; 40 | — |
| SECONDARY Language Outcome |
12; 5; 24; 7 | — |
Summary
The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.
Eligibility Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00033917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.