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Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
Not Recruiting
Trial ID: NCT00009620
Purpose
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.
Official Title
Randomized Clinical Trial of Antenatal Phenobarbital in the Prevention of Neonatal Intracranial Hemorrhage
Stanford Investigator(s)
Eligibility
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
Intervention(s):
drug: Phenobarbital
drug: Saline
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305