UNLABELLED: ōk--q----_xD-xD whether maternal antenatal therapy with vitamin K and phenobarbital prevents intracranial hemorrhage in premature newborns. METHODS:Women at high risk for spontaneous or indicated premature delivery before 34 weeks' gestation were randomly assigned to receive either placebo or vitamin K and phenobarbital. All patients received betamethasone and antibiotics and were managed uniformly by a single perinatal group in one hospital. All newborns were managed uniformly in the same nursery by one neonatal group. Two independent interpretations of neonatal head ultrasound examinations were obtained. RESULTS: The duration of gestation at study entry and at delivery were similar in the placebo (181 mothers) and treatment (191) groups. With the hospital radiology group (the primary interpreter), the incidence rates of severe intracranial hemorrhage (8 versus 7%) and mild intracranial hemorrhage (38 versus 32%) were similar for both groups. With the secondary interpreter (a single pediatric radiologist), the incidence rates of severe intracranial hemorrhage (9 versus 7%) and mild intracranial hemorrhage (27 versus 26%) were also similar. Neonatal mortality was equivalent in both the placebo and treatment groups (8 versus 10%). CONCLUSION: Combined antenatal therapy with vitamin K and phenobarbital does not reduce the frequency or severity of intracranial hemorrhage in premature newborns.
RCT Entities:
UNLABELLED: ōk--q----_xD-xD whether maternal antenatal therapy with vitamin K and phenobarbital prevents intracranial hemorrhage in premature newborns. METHODS:Women at high risk for spontaneous or indicated premature delivery before 34 weeks' gestation were randomly assigned to receive either placebo or vitamin K and phenobarbital. All patients received betamethasone and antibiotics and were managed uniformly by a single perinatal group in one hospital. All newborns were managed uniformly in the same nursery by one neonatal group. Two independent interpretations of neonatal head ultrasound examinations were obtained. RESULTS: The duration of gestation at study entry and at delivery were similar in the placebo (181 mothers) and treatment (191) groups. With the hospital radiology group (the primary interpreter), the incidence rates of severe intracranial hemorrhage (8 versus 7%) and mild intracranial hemorrhage (38 versus 32%) were similar for both groups. With the secondary interpreter (a single pediatric radiologist), the incidence rates of severe intracranial hemorrhage (9 versus 7%) and mild intracranial hemorrhage (27 versus 26%) were also similar. Neonatal mortality was equivalent in both the placebo and treatment groups (8 versus 10%). CONCLUSION: Combined antenatal therapy with vitamin K and phenobarbital does not reduce the frequency or severity of intracranial hemorrhage in premature newborns.