Effect of withholding phenobarbitone maintenance therapy in neurodevelopmental outcome at 1 year of age in neonatal seizures

Objective: To investigate effect of withholding phenobarbitone maintenance therapy in neurodevelopmental outcome at 1 year of age in neonatal seizures Materials and Methods: Design: This study was conducted to evaluate neurodevelopmental assessment at 1 year of age of babies enrolled in a previous interventional randomized controlled trial done at our NICU. Participants: 152 late preterm and term infants were allocated to phenobarbitone maintenance group (n=77) or placebo group (n=75). We enrolled late preterm and term infants with seizures after receiving loading dose of phenobarbitone. Both phenobarbitone maintenance and placebo group participants were followed at 1 year of age and neurodevelopmental screening was done by Denver II. Outcome measure(s): Outcome was abnormal examination through Denver II at follow up at 12-18 months and to measure seizure recurrence & rehospitalisation in both groups. Results: 152 babies were enrolled in this study. Outcome data was available for 92 (85.2 %) of the 108 alive infants at 1 year of age. The baseline characteristics of the babies in 2 groups were comparable. Abnormal examination as per Denver II occurred in 19/43 (44.19%) subjects in placebo group and 21/49 (42.86%) in phenobarbitone group. Seizure recurrence and rehospitalisation till 1 year of age were comparable in both groups. Conclusion: This study concluded that withholding phenobarbitone maintenance immediately after loading dose of phenobarbitone in neonatal seizures does not result in worsening of neurodevelopmental outcome, or mortality and recurrence of seizures till 1 year of age.