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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00009620 |
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.
Condition | Intervention | Phase |
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Intracranial Hemorrhage Brain Injury Brain Hemorrhage |
Drug: phenobarbital |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Randomized Clinical Trial of Antenatal Phenobarbital in the Prevention of Neonatal Intracranial Hemorrhage |
Estimated Enrollment: | 1038 |
Study Start Date: | January 1993 |
Estimated Study Completion Date: | February 1995 |
The administration of phenobarbital to pregnant women before delivery has been thought to decrease the frequency of intracranial hemorrhage in preterm infants. To evaluate this potential neuroprotective therapy further, we determined the effect of antenatal administration of phenobarbital on the frequency of neonatal intracranial hemorrhage and early death. Women who were 24 to 33 weeks pregnant and who were expected to deliver their infants within 24 hours were randomly assigned to receive either intravenous phenobarbital (10 mg/kg body weight) or placebo, followed by maintenance doses until delivery or 34 wks gestation. Infants less than 34 wks at birth underwent serial cranial ultrasonography to detect the presence of intracranial hemorrhage. The sample size of 1038 pregnancies was based on an intracranial hemorrhage rate of 20 percent in the placebo and less than 12 percent in the phenobarbital group; 90 percent power; a 5 percent two-tailed type 1 error; and an 8 percent noncompliance rate. The twin with the highest grade of intracranial hemorrhage was included.
Degree of maternal sedation was evaluated after administration of study drug. Neonatal ultrasound exams were performed at 3-5 days, 10-14 days, and 38-42 wks postmenstrual age; neonatal medications were recorded during the first week of life; treatments, and outcomes were recorded through death, discharge, or 120 days, whichever occurred first. Neurodevelopmental outcome was evaluated at 18-22 months corrected age by certified examiners masked to treatment status.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | NICHD-1000 |
Study First Received: | February 1, 2001 |
Last Updated: | February 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00009620 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cerebral hemorrhage Phenobarbital/administration Pregnancy Prenatal care Infant, newborn |
Craniocerebral Trauma Excitatory Amino Acids Neurotransmitter Agents Cerebral Hemorrhage Phenobarbital Vascular Diseases Wounds and Injuries Central Nervous System Depressants Central Nervous System Diseases |
Disorders of Environmental Origin Intracranial Hemorrhages Trauma, Nervous System Hemorrhage Brain Diseases Cerebrovascular Disorders Hypnotics and Sedatives Brain Injuries Anticonvulsants |
Craniocerebral Trauma Phenobarbital Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Disorders of Environmental Origin Excitatory Amino Acid Agents Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders Pathologic Processes Therapeutic Uses |
Hypnotics and Sedatives Cardiovascular Diseases Brain Injuries Excitatory Amino Acid Antagonists Nervous System Diseases Wounds and Injuries Vascular Diseases Central Nervous System Diseases Central Nervous System Depressants Trauma, Nervous System Pharmacologic Actions GABA Agents Central Nervous System Agents Anticonvulsants |