Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

• Status: Completed
• Trial end date: 1997-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Phenobarbital

Criteria

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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