A randomized controlled trial on comparison of phenobarbitone and levetiracetam for the treatment of neonatal seizures: pilot study

Abstract

Background: Phenobarbitone is the most commonly used drug for treatment of neonatal seizures, irrespective of the cause of the seizures. However, there is concern about its adverse effects on brain, resulting in impairment of cognition and behaviour, and liver. So there is an urgent need for an alternative antiepileptic drug for treatment of neonatal seizures. Levetiracetam is a relatively new anticonvulsant. There are no randomized controlled trials about its use in neonates. This trial was designed with the objective to compare the efficacy of levetiracetam and phenobarbitone in the treatment of clinically apparent neonatal seizures in term and late preterm neonates. Methods: The study was designed as an open label randomized controlled trial. Study population included babies of >2 kg admitted in Neonatal Intensive Care Unit within 48 hours of birth with neonatal seizures due to perinatal asphyxia. If seizures persisted even after correction of hypoglycemia and hypocalcaemia, babies were randomized for intervention to either levetiracetam or phenobarbitone. Results: Clinically apparent seizures were controlled in only 23.3% neonates assigned to receive levetiracetam as compared to 86.7% neonates assigned to receive phenobarbitone (p Conclusions: Present study demonstrated that levetiracetam is not as good as phenobarbitone in controlling neonatal seizures due to perinatal asphyxia in term and near term neonates. Also, it takes longer time than phenobarbitone in controlling clinical seizures. Superiority of phenobarbitone was observed both when given as a first line drug and after cross over.Key words: Neonatal seizures, Phenobarbitone, Levetiracetam