Comparative Efficacy of Levetiracetam versus Phenobarbitone as First-Line Treatment for Neonatal Seizures

Abstract

Objectives: The study aimed to compare the efficacy and safety of levetiracetam versus phenobarbitone as first-line treatment for neonatal seizures. Material and Methods: This randomized control trial was conducted from March 2018 to July 2018 at the special new born care unit, Coimbatore Medical College Hospital. Neonates admitted for seizures were randomly assigned to receive either levetiracetam or phenobarbitone as their initial anticonvulsant. Group A received levetiracetam starting at a dose of 10 mg/kg twice daily, escalating to 40 mg/kg twice daily if necessary. Group B received phenobarbitone, at a dose of 20 mg/kg slow IV infusion. Primary outcome included clinical seizure control and time taken for seizure control, while secondary outcomes measured included shock, apnea, respiratory failure, and mortality. Babies treated with anticonvulsants before admission were excluded from the study. Results: Out of 68 neonates admitted, 52 were eligible for the study after excluding 16 pre-treated with anticonvulsants. Both groups consisted of 26 neonates each. Clinical seizure control was achieved in 53.8% of the levetiracetam group and 61.5% of the phenobarbitone group. Complications were included shock (11.5% with levetiracetam and 15.3% with phenobarbitone), apnea (0% with levetiracetam and 7.7% with phenobarbitone), and respiratory failure (7.75% in both groups). Mortality rates were identical at 11.5% for both groups. No significant difference in seizure control or complications was observed between the groups. Levetiracetam did not exhibit major side effects, indicating it can be considered a viable first-line drug for neonatal seizures. However, the small sample size necessitates larger trials for confirmation. Conclusion: Levetiracetam and phenobarbitone demonstrated comparable efficacy and safety as first-line treatments for neonatal seizures. While levetiracetam showed promise with fewer side effects like apnea, further large scale, prospective randomized trials are required to establish definitive conclusions and optimize dosing strategies. This study contributes to the ongoing discussion on the best first-line anticonvulsant for neonatal seizures and suggests levetiracetam as a potential alternative to phenobarbitone.