CTRI/2015/06/005849已完成Phase 3 4
Levetiracetam vs Phenobarbitone in acute neonatal seizures - a Randomised Control Trial
Dr Nikhil D Kulkarni1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年1月10日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Recurrence of seizure and need for another anticonvulsant.
研究概览
简要总结
Hypothesis: In acute management of neonatal seizures, intravenous Levetiracetam 30 mg/kg/dose as against 20 mg/kg/dose of Phenobarbitone achieves 50% more seizure control clinically at 7 days as compared to Phenobarbitone.
Purpose: To find a better, safe and effective anticonvulsant in the management of acute neonatal seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Month(s)（—）
- 性别
- All
入选标准
- •> 1000 g birth weight and > 28 weeks gestation.
- •all term neonates.
排除标准
- •hypoglycemic seizures 2)neonates treated with anticonvulsants prior to admission.
结局指标
主要结局
Recurrence of seizure and need for another anticonvulsant.
时间窗: Immediately on the day of seizure i.e. within 24 hours.
次要结局
- Monitoring of adverse drug reactions of each drug like Phenobarbitone toxicity, mortality and neurodevelopmental follow up in follow up clinic.(After treatment of seizures within 7 days and on followup at 1 month, 3 months,6 months, 9 months, 12 months, 15 months, 18 months and 24 months.)
研究者
研究点 (1)
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