CTRI/2013/04/003585招募中Phase 3 4
Levetiracetam in neonatal seizures -a randomised study
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To study the therapeutic benefit of levetiracetum in neonatal seizures and to compare efficacy with other antiseizure medication.
研究概览
简要总结
to study the therapeutic benefit of levetiracetam in neonatal seizures and to compare efficacy with other anticonvulsant medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 30.00 Day(s)（—）
- 性别
- All
入选标准
- •Babies admitted to NICU with seizures and babies having seizures during NICU stay with •Gestational age ≥ 30 wks Birth weight ≥ 1.5 kg Clinical or electrographic seizures Parental consent obtained.
排除标准
- •Babies with renal serum creatinine > 2.0 Birth at < 30 weeks gestation Parents refuse consent.
结局指标
主要结局
To study the therapeutic benefit of levetiracetum in neonatal seizures and to compare efficacy with other antiseizure medication.
时间窗: 30/06/2013
次要结局
- use of leviteracetam in various types of neonatal seizures(30/6/2013)
研究者
研究点 (1)
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