Infantile Spasms, West Syndrome
Conditions
Brief summary
Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no consensus on the dosage of Prednisolone required for the treatment of infantile spasms. Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses. A higher steroid dose may also be associated with more side effects. Therefore, this study was planned to compare the efficacy and tolerability of the high dose versus the usual dose in children with infantile spasms, in a randomized open-label trial design
Interventions
Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day
Sponsors
Lady Hardinge Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
\- Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants
Exclusion criteria
1. Children with active systemic illness 2. Children with evidence of active tuberculosis 3. Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference \< 11 cm/pedal edema/Weight for height \< 3 SD) 4. Children with recurrent illness/chronic systemic illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of children with adverse effects | 14 days |
Countries
India
Outcome results
None listed