CompletedPhase 3

Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

United States610 participantsStarted 1993-02

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Neonatal intracranial hemorrhage or death

Timeframe: 72 hours of life

Trial details

NCT IDNCT00009620

SponsorNICHD Neonatal Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion1995-02

View on ClinicalTrials.gov More Infant, Newborn trials