title: High-dose phenobarbital therapy in term newborn infants with severe perinatal asphyxia: a randomized, prospective study with three-year follow-up.
abstract: OBJECTIVE
  To determine whether 40 mg/kg phenobarbital given to term infants with severe asphyxia would result in a lower incidence of seizures in the newborn period and an improved neurologic outcome.
  
  
  METHODS
  We conducted a randomized, controlled, prospective study. Entry criteria included (1) an initial arterial pH less than or equal to 7.0 with a base deficit 15 mEq/L or more, (2) Apgar score less than or equal to 3 at 5 minutes of age, or (3) failure to initiate spontaneous respiration by 10 minutes of age. Sample size was calculated to detect a 50% reduction in the incidence of neonatal seizures.
  
  
  RESULTS
  No differences were present between treatment and control groups with respect to severity of asphyxia assessed by initial arterial pH, base excess, cerebrospinal fluid lactate dehydrogenase concentration or detection of CSF creatine kinase of its BB isoenzyme. Seizures occurred in 9 of 15 infants in the treatment group and 14 of 16 infants in the control group (p = 0.11). No adverse effects were observed from phenobarbital on heart rate, respiratory rate, blood pressure, or arterial blood gas values. Three-year follow-up revealed normal outcome in 11 of 15 infants in the treatment group and 3 of 16 in the control group (p = 0.003).
  
  
  CONCLUSIONS
  Phenobarbital, when administered in a dose of 40 mg/kg intravenously over 1 hour in term, severely asphyxiated newborn infants appeared to be safe and was associated with a 27% reduction in the incidence of seizures and a significant improvement in neurologic outcome at 3 years of age.
authors.affiliation: Department of Pediatrics, University of Missouri-Kansas City School of Medicine, USA.
authors.forename: R T
authors.initials: RT
authors.lastname: Hall
authors.forename: F K
authors.initials: FK
authors.lastname: Hall
authors.forename: D K
authors.initials: DK
authors.lastname: Daily
mesh_terms: D000927:Anticonvulsants / Q000008:administration & dosage / Q000627:therapeutic use*; D001238:Asphyxia Neonatorum / Q000150:complications* / Q000378:metabolism; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D010634:Phenobarbital / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D012044:Regression Analysis; D012640:Seizures / Q000209:etiology / Q000378:metabolism / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D010634:Phenobarbital