CTRI/2013/01/003310招募中3 期
comparison of levetiracetam with phenobarbitone for the treatment of seizure in term and near term neonates.
未提供1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年11月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- control of clinical seizure
研究概览
简要总结
Phenobarbitone is the drug of choice in neonatal seizure but known to have long term effect on neonatal brain..Levetiracetam is a newer antiepileptic and its efficacy not being fully established in neonates. It has not been known to have abnormal nuerological effect instead in previous studies it has been to be proved to have nueroprotective..so it has been compared with phenobarbitone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •all newborns <28 days with convulsions of any cause.
排除标准
- •babies on mechanical ventilation and with refractory shock.
结局指标
主要结局
control of clinical seizure
时间窗: 24 hrs
次要结局
- side effects of levetiracetam(nuerological outcome at age 3,6,12 months)
研究者
研究点 (1)
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