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Background 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.
Methods We studied 610 women who were 24 to 33 weeks pregnant and who were expected to deliver their infants within 24 hours. The women were randomly assigned to receive either phenobarbital (10 mg per kilogram of body weight) or placebo intravenously, followed by maintenance doses until delivery or 34 weeks of gestation. The infants born to these women underwent cranial ultrasonography to detect the presence of intracranial hemorrhage.
Results There were 309 women in the phenobarbital group and 301 in the placebo group. A total of 247 women (80 percent) in the phenobarbital group and 235 (78 percent) in the placebo group delivered within 24 hours after infusion of the study drug or administration of the last maintenance dose. Intracranial hemorrhage or early death occurred in 83 of the 344 infants born to the women in the phenobarbital group (24 percent) and in 74 of the 324 born to the women in the placebo group (23 percent; risk ratio for the infants in the phenobarbital group, 1.1; 95 percent confidence interval, 0.8 to 1.4). Among infants born before 34 weeks' gestation in whom ultrasonographic studies were performed, intracranial hemorrhage was diagnosed in 70 of 311 infants in the phenobarbital group (23 percent) and 64 of 279 in the placebo group (23 percent; risk ratio, 1.0; 95 percent confidence interval, 0.8 to 1.4).
Conclusions Antenatal administration of phenobarbital does not decrease the risk of intracranial hemorrhage or early death in preterm infants.
Source Information
From Wayne State University, Detroit (S.S.); the University of New Mexico, Albuquerque (L.-A.P.); the National Institute of Child Health and Human Development, Bethesda, Md. (L.L.W.); Yale University, New Haven, Conn. (R.A.E.); George Washington University Biostatistics Center, Rockville, Md. (L.M.); Indiana University, Indianapolis (J.A.L.); University of Tennessee at Memphis, Memphis (S.B.K.); Stanford University, Palo Alto, Calif. (D.K.S.); University of Cincinnati, Cincinnati (E.F.D.); Emory University, Atlanta (B.J.S.); Case Western Reserve University, Cleveland (A.A.F.); and Women and Infants Hospital, Providence, R.I. (W.O.). Other authors were Joel Verter, Ph.D. (George Washington University Biostatistics Center, Rockville, Md.); George A. Taylor, M.D. (Harvard University, Boston); JoAnna Seibert, M.D. (University of Arkansas, Little Rock); and Michael DiPietro, M.D. (University of Michigan, Ann Arbor).
Address reprint requests to Dr. Shankaran at Children's Hospital of Michigan, 3901 Beaubien Blvd., Detroit, MI 48201.
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