Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

Completed · Phase 3 · Has a placebo group

Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Intracranial Hemorrhages

In brief

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.

Key facts

Study ID

NCT00009620

Run by

NICHD Neonatal Research Network

People needed

610

Starts

1993-02-01

Expected to finish

1997-02-01

Last updated by the study team

2019-03-22

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Admission to a high risk perinatal unit or labor and delivery unit;
• 24 to 32 completed weeks gestation;
• Expected delivery within 24 hrs;
• Preterm labor or no labor with planned delivery for maternal-fetal indications;

You may not qualify if…

• Anticipated delivery within two hours
• Multiple congenital or chromosomal abnormalities in the fetus
• Multiple gestation with more than two fetuses
• Administration of phenobarbital during the pregnancy
• Administration of indomethacin within one week before admission
• Maternal platelet count of less than 100,000 per cubic millimeter

Where it is running

• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Tennessee — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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