At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 610 enrolled

Drug / intervention

Phenobarbital +1 moredrug

Likely dose

Phenobarbital 10 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00009620

NCT00009620Phase 3Completed

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Randomized Clinical Trial of Antenatal Phenobarbital in the Prevention of Neonatal Intracranial Hemorrhage

NICHD Neonatal Research Network·interventional·Posted Feb 5, 2001·Updated Mar 22, 2019

In Brief

A Phase 3 clinical trial evaluating Phenobarbital and Saline for Infant, Newborn and 4 related conditions. Completed, enrolled 610 participants across 11 sites.

Detailed Summary

This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to 32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were randomized to phenobarbital or usual care. They were treated until they deliver or the fetus reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos corrected age for neurodevelopmental outcome.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Intracranial Hemorrhages

CountriesUnited States

CollaboratorsNational Center for Research Resources (NCRR)

Timeline

Phase 3CompletedFinished

19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 1993

Primary CompletionFeb 1995

Study CompletionFeb 1997

First PostedFeb 2001

TodayJul 2026

First PostedFeb 5, 2001

Enrollment StartFeb 1, 1993

Primary CompletionFeb 1, 1995

Study CompletionFeb 1, 1997

TodayJul 1, 2026

Enrollment to primary: 2 yearsPosted 25.4 years ago

Interventions

Phenobarbitaldrug

10 mg of phenobarbital per kilogram of body weight intravenously over a period of 20 to 40 minutes (maximal dose, 1000 mg)

Salinedrug

Infusion of normal sal