Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

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.

Conditions

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

Interventions

DRUG

Phenobarbital

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

DRUG

Saline

Infusion of normal sal

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Seetha Shankaran, MD · Wayne State University

• Lu-Ann Papile, MD · University of New Mexico

• Richard A. Ehrenkranz, MD · Yale University

• Raymond Bain, PhD · George Washington University

• James A. Lemons, MD · Indiana University

• Sheldon B. Korones, MD · University of Tennessee at Memphis

• David K. Stevenson, MD · Stanford University

• Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

• Barbara J. Stoll, MD · Emory University

• Avroy A. Fanaroff, MD · Case Western Reserve University

• William Oh, MD · Brown University, Women and Infants Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1993-02-28

Primary Completion

1995-02-28

Completion

1997-02-28

Countries

• United States

Study Locations