Abstracts

Infantile spasms is a severe epilepsy with a high risk of poor developmental outcome. Management is controversial with insufficient information on the best initial treatment. We undertook a randomised controlled trial of 107 infants, comparing hormonal treatments (prednisolone or tetracosactide) with vigabatrin. Minimum doses per day were: vigabatrin 100mg/kg, oral prednisolone 40mg, IM tetracosactide depot 0.5mg (40iu) alt days. Baseline characteristics were well matched. Control of spasms at 14 days was: hormonal treatments 40/55 (73%) vigabatrin 28/52 (54%) difference 19% (95% confidence interval 1% to 36% p[lt]0.043). We report developmental outcome. Vineland adaptive behaviour scales (VABS) were administered by 1 researcher at 14 months. VABS composite scores were analysed without transformation by one-way analysis of variance with randomised treatment as the grouping factor. Individual (single degree of freedom) contrasts were extracted to compare (i) vigabatrin with the combined hormonal treatments, and (ii) the two hormonal treatments with each other. Analysis was by intention to treat and was conducted using the BMDP release 7, program 7D. [table1]No significant differences were seen. [vigabatrin v combined hormonal treatments F=0.09, df=1,98, P=0.76; difference (95%CL): 0.9 (-5.0 to 6.8)] [prednisolone v tetracosactide F=0.04, df=1,98, P=0.84; difference (95%CL): 0.8 (-7.4 to 9.1)]. No difference in developmental outcome was seen despite the difference in control of spasms at 14 days. It is possible that more prolonged or detailed follow up will detect a difference or there is no difference. It is not known if better control of spasms will improve developmental outcome in the longer term. (Supported by Bath Unit for Research in Paediatrics, Wellcome Trust (FJKOC), Cow and Gate (EH, AL))