Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants
排除标准
- •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
研究组 & 干预措施
High dose
Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days
干预措施: Oral prednisolone (Drug)
Usual dose
Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days
干预措施: Oral prednisolone (Drug)
结局指标
主要结局
Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .
时间窗: 14 days
次要结局
- Proportion of children with adverse effects(14 days)
研究者
Satinder Aneja
Director Professor
Lady Hardinge Medical College