High dose (4 mg/kg/day) versus usual dose (2 mg/kg/day) oral prednisolone for treatment of infantile spasms: An open-label, randomized controlled trial

•We studied high dose versus low dose prednisolone for treatment of spasms.•Spasm freedom was significantly higher in the high dose prednisolone group.•Hypsarrythmia resolution was not significantly different.•High dose prednisolone was safe in children with spasms.

SummaryObjectivesThis study aimed to test the hypothesis that high-dose prednisolone (4 mg/kg/day) may be more efficacious than usual-dose (2 mg/kg/day) prednisolone for spasm resolution at 14-days in children with infantile spasms.MethodsThis was a randomized, open-label-trial conducted at a tertiary-level-hospital from February-2012 to March-2013. Children aged 3-months to 2-years presenting with infantile spasms in clusters (at least 1 cluster/day) with hypsarrhythmia or its variants on EEG were enrolled. The study participants were randomized to receive either high-dose prednisolone (4 mg/kg/day) or the usual-dose (2 mg/kg/day) prednisolone. The primary outcome measure was the proportion of children who achieved spasm freedom for 48-h at day-14 after treatment initiation as per parental reports in both the groups. The adverse effects were also monitored. The study was registered with the clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT01575639).ResultsSixty-three children were randomized into the two groups with comparable baseline characteristics. The proportion of children with spasm cessation on day-14 was significantly higher in the high-dose group as compared to the usual-dose group (51.6% vs. 25%, p = 0.03). The absolute risk reduction was 26.6% (95% confidence interval 11.5–41.7%) with number needed to treat being 4. The adverse effects were comparable in both the groups.ConclusionsHigh-dose prednisolone (4 mg/kg/d) was more effective than low-dose prednisolone (2 mg/kg/d) in achieving spasm cessation at 14-days (as per parental reports) in children with infantile spasms.