Effect of Withholding Phenobarbitone Maintenance in Neonatal Seizures: A Randomized Controlled Trial

To compare the effect of withholding maintenance phenobarbitone on breakthrough seizures.

A double blind randomized controlled trial.

Level II neonatal intensive care unit (NICU) of a teaching hospital in Northern India.

152 term and near term neonates (34 weeks of gestation age) with admission weight ≥2 kg with clinically apparent seizures who received intravenous (IV) loading dose of 20 mg/kg of phenobarbitone.

After 12 hours of seizure free period of the initial loading dose of phenobarbitone, one group received IV maintenance therapy and other 'no maintenance' (saline as placebo).

Breakthrough seizures from randomization till discharge.

Baseline variables were comparable in the two groups. Breakthrough seizures occurred in 30 (40%) subjects in placebo group and 24 (31.2%) in phenobarbitone group with RR (95% CI) of 1.28 (0.83-1.97) (P=0.19). Seizure recurrence, re-hospitali-sation, mortality and abnormal neurological assessment until 3 months were comparable in the two groups (P>0.05). Babies in either group with breakthrough seizures were more likely to be neurologically abnormal at 1 month than babies who did not have breakthrough seizures, but this difference decreased by 3 months.

In term and near-term neonates, those who respond to loading dose of phenobarbitone after a single seizure episode, withholding of phenobarbitone maintenance may not significantly increase the risk of breakthrough seizures.