Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.
Overview
- Phase
- Phase 3
- Intervention
- Oral prednisolone
- Conditions
- Infantile Spasms
- Sponsor
- Lady Hardinge Medical College
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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
Investigators
Satinder Aneja
Director Professor
Lady Hardinge Medical College
Eligibility Criteria
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
- •Children with active systemic illness
- •Children with evidence of active tuberculosis
- •Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference \< 11 cm/pedal edema/Weight for height \< 3 SD)
- •Children with recurrent illness/chronic systemic illness
Arms & Interventions
High dose
Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days
Intervention: Oral prednisolone
Usual dose
Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days
Intervention: Oral prednisolone
Outcomes
Primary Outcomes
Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .
Time Frame: 14 days
Secondary Outcomes
- Proportion of children with adverse effects(14 days)