Ketogenic Diet for Status Epilepticus in Infants, Children and Adolescents Aged 6 Months to 18 Years Immediately After Cessation of Convulsive Status Epilepticus; a Randomized Open Labelled Trial

Study Title : Ketogenic diet for status epilepticus in infants, children and adolescents aged 6 months to 18 years immediately after cessation of convulsive status epilepticus; a randomized open labelled trial Objective of The study : To evaluate the efficacy of add on ketogenic diet therapy compared to standard treatment and care of infants, children and adolescents aged 6 months to 18 years in terms of time taken for reduction in EEG discharges by >50% (with a baseline of abundant or frequent discharges) after stoppage of convulsive status epilepticus Justification of the study: Up to one third of epilepsy are medically intractable, of which only another third is surgically amenable. Ketogenic diet is now an established modality of treatment in these 20 percent of patients with epilepsy. Various studies have shown at least up to 50% reduction in seizure frequency with this modality.

The last decade has seen ketogenic diet being used for management of status epilepticus. Current evidence is only in the form of case series and isolated case reports. Status epilepticus is associated with significant mortality and morbidity. Aggressive management is imperative. However, non-convulsive electrographic status may persist beyond cessation of clinical status in up to 20-30% of cases. Thus in such scenarios, it is controversial whether to continue aggressive management with anesthetics and numerous antiepileptics, as the effect may be detrimental. Thus, the current study has been planned to evaluate efficacy of ketogenic diet in status epilepticus.

Study design: Open labeled randomized controlled trial Study population: Infants, children and adolescents aged 6 months to 18 years with electrographic evidence of seizure activity with abundant or frequent discharges immediately after stoppage of convulsive status epilepticus, attending pediatric inpatient services at AIIMS, New Delhi Assuming time to cessation of reduction of EEG discharges by > 50% to be 10+5 days in the KD arm and 15+5 in the non KD arm, with an alpha of 5% and power of 90%, the sample size comes out to be 22 in each arm. It is being proposed that 25 cases will be recruited in each of the arms.

Inclusion criteria

1. Infants, children and adolescents aged 6 months to 18 years
2. Electrographic evidence of seizure(frequent or abundant discharges in EEG)
3. Clinical status controlled immediately on standard therapy and care based on established consensus guidelines followed globally Exclusion criteria