Levetiracetam versus Phenobarbitone in Neonatal Seizures — A Randomized Controlled Trial

Objective To compare the efficacy and safety of intravenous Levetiracetam and Phenobarbitone in the treatment of neonatal seizures. Design Open labelled, Randomized controlled trial. Setting Level III Neonatal Intensive Care Unit (NICU). Participants 100 neonates (0–28 days) with clinical seizures. Intervention If seizures persisted even after correction of hypoglycemia and hypocalcemia, participants were randomized to receive either Levetiracetam (20 mg/kg) or Phenobarbitone (20 mg/kg) intravenously. The dose of same drug was repeated if seizures persisted (20 mg/kg of Levetiracetam or 10 mg/kg of Phenobarbitone) and changeover to other drug occurred if the seizures persisted even after second dose of same drug. Main outcome measures Cessation of seizures with one or two doses of the first drug, and remaining seizure-free for the next 24 hours. Results Seizures stoped in 43 (86%) and 31 (62%) neonates in Levetiracetam and Phenobarbitone group, respectively (RR 0.37; 95%CI 0.17, 0.80, P