Phase 3 Completed N=431 Randomized Double-blind Prevention

Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial

Intraventricular Hemorrhage (IVH) · Bleeding in the Brain · prematurity · Very Low Birth Weight Infants

Source: ClinicalTrials.gov NCT00033917 ↗

Enrolled (actual)

431

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcomePrimary: IVH at 5 Postnatal Days — 25; 40 IVH

Summary

The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.

Outcome Measures

Outcome	Result	p-value
PRIMARY IVH at 5 Postnatal Days	25; 40	—
SECONDARY Language Outcome	12; 5; 24; 7	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.