NEONATAL SEIZURES – LEVETIRACETAM VERSUS PHENOBARBITAL

Background: Neonatal seizures (NS) are an important cause of admission in the neonatal intensive care units (NICU) in India. While the drug which stood the test of time is phenobarbitone (PB), levetiracetam (LEV) may be a better alternative with superior effects. Objective: The objective of the study was to compare the efficacy of LEV and PB for the treatment and follow-up of term neonates with NS. Materials and Methods: This open-labeled randomized controlled trial was carried out on 80 newborn babies suffering from clinically apparent seizures who were admitted in a tertiary care NICU of Bihar. All admitted term neonates who were without transient metabolic disorders (hypoglycemia or hypocalcemia) were randomly assigned. LEV (n=42) at an intravenous (IV) doses of 10 mg/kg was gradually increased to 15 mg/kg and PB (n=38) at a dose of 20 mg/kg/dose IV over 20 min gradually increased in aliquots of 10 mg/kg up to 40 mg/kg total dose. Neonates whose seizures were not controlled by the assigned drug were then crossed over to be treated with the other drug in same dose. Results: Clinical features and baseline characteristics were compared in both groups. Seizures were controlled in 66.6% neonates who received LEV, as compared to 81.5% neonates who received PB (p>0.05). Short-term adverse effects (cardiorespiratory depression and sedation) were noted in 52.6% babies in PB group in comparison to 7.1% babies in LEV group (p<0.05). Long-term neuromotor and developmental complications were less in LEV group as compared to PB group (p<0.05) at 1 year of age. Conclusion: LEV and PB, both were equally effective in control of clinical seizures irrespective of the etiology, but LEV is superior in terms of short- and long-term neurodevelopmental outcomes than PB.