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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
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
Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, National Capital Territory of Delhi, India
Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .
Time frame: 14 days
Proportion of children with adverse effects
Time frame: 14 days
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