Oral Dexamethasone versus Prednisolone for Management of Children with West Syndrome: An Open-Labeled Randomized Controlled Pilot Trial.

OBJECTIVE

To compare the efficacy of oral dexamethasone and prednisolone in the treatment of newly diagnosed children aged 3-36 months of West syndrome.

METHODS

An open-labeled, randomized controlled clinical trial with parallel group assignment was conducted among children aged 3-36 months with newly diagnosed West syndrome. They were randomized to receive either oral dexamethasone (0.6 mg/kg/day QID) (n = 20) or oral prednisolone (4 mg/kg/day BD) (n = 20). Proportion of children who achieved spasm freedom at 2 weeks was the primary outcome. Secondary outcome measures were proportion of children who achieved electroclinical resolution, greater than 50% reduction in spasms frequency, time to cessation of spasms, and adverse effects at 2 weeks.

RESULTS

The efficacy of oral dexamethasone was comparable to oral prednisolone in terms of proportion of children who achieved spasms cessation (13 [65%] vs. 8 [40%]; = 0.21), electroclinical remission (13 [65%] vs. 8 [40%] = 0.21), greater than 50% reduction of spasms (3 [15%] vs. 7 [35%] = 0.65), and time to cessation of spasms (5.31 [2.81] vs. 4.37 [1.41] = 0.39). Adverse effect profile was also comparable with irritability (18 [90%] vs. 12 [60%] = 0.06] being most common.

CONCLUSION

There was no difference in electroclinical remission at 2 weeks between oral dexamethasone and prednisolone in children with infantile spasms in this small pilot trial. Further evaluation is suggested with an adequately powered study and long-term follow-up.