Phenobarbitone versus Levetiracetam as 1st line therapy for Neonatal Seizures- A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Termination of clinical seizures (seizure control in 60 minutes and no further seizure in 24 hours)
研究概览
简要总结
•Neonatal seizures affect 1 to 4/1000 newborns and are associated with poor outcomes.
•Up to one third of the infants with neonatal seizures die, and half of survivors have permanent disabilities.
•Mortality and morbidity of neonatal seizures are in large part attributed to the underlying condition; however, there is mounting evidence that seizures themselves are harmful, especially in the asphyxiated neonatal brain.
•Phenobarbital is the most frequently used first line anti-epileptic drug for neonatal seizure, however, phenobarbitone is effective in controlling seizure in 40-70% of babies only.
•Levetiracetam has good efficacy and an excellent safety profile in children and adult population.
•Because the neonatal response to anticonvulsants is fundamentally different from that of the older brain, specific study of levetiracetam within the neonatal population is essential
•Drugs that are effective in terminating seizures in older patients may be less effective and more toxic in neonates.
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
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All term and late pre-term neonates (>35weeks of gestation) with clinically apparent seizures and lasting for 3 minutes.
排除标准
- •Neonates-
- •Who had received any previous anticonvulsants.
- •With correctable metabolic abnormalities(like hypoglycemia/hypocalcemia)
- •With myoclonic jerks.
- •With major congenital malformation or syndromes.
结局指标
主要结局
Termination of clinical seizures (seizure control in 60 minutes and no further seizure in 24 hours)
时间窗: Termination of clinical seizures (seizure control in 60 minutes and no further seizure in 24 hours)
次要结局
- 1. Cessation of Seizure for 48 hours(2. Survival at discharge)