CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 630 enrolled
Drug / intervention
indomethacin +1 moredrug
Likely dose
Indomethacin (dosing regimen not specified in provided text)AI-extracted
Key inclusion· 2
  • ✓Preterm infants with birth weight <1250 g
  • ✓Admitted to participating institution within 6 hours of age
Key exclusion· 2
  • ✕Evidence of congenital malformations
  • ✕Grades III–IV intraventricular hemorrhage on cranial ultrasound at 6 postnatal hours

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00033917
NCT00033917Phase 3Completed
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Randomized Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial

Yale University·interventional·Posted Apr 15, 2002·Updated Mar 28, 2013

In Brief

A Phase 3 clinical trial evaluating indomethacin and placebo for Intraventricular Hemorrhage (IVH) and 3 related conditions. Completed, enrolled 630 participants across 3 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntraventricular Hemorrhage (IVH), Bleeding in the Brain, Prematurity, Very Low Birth Weight Infants
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 15, 2002
Enrollment StartSep 1, 1989
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 22.5 yearsPosted 24.2 years ago

Interventions

indomethacindrug

an anti-inflammatory drug

placebodrug

saline