The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children: Multicenter Retrospective Study on 151 Children Over Three Months Old
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN
研究概览
简要总结
Status epilepticus is the leading neurological emergency in children, with mortality 2-7% and significant morbidity (10-20%). It is defined as the occurrence of a crisis lasting more than 5 minutes and requiring the implementation of treatment to stop it and thus limit the immediate and long-term consequences.
The research hypothesis is that LEVETIRACETAM is non-inferior to PHENYTOIN in terms of cessation and absence of recurrence of status epilepticus, with better clinical tolerance in children from 3 months to 17 years old, with or without epileptic disease, with or without a history of status epilepticus
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minor patient aged 3 months to 17 years
- •2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines
- •Supported in one of the participating centers during the period from November 1, 2019 to May 31, 2023
- •Subject or parents who have not expressed, after information, their opposition to the reuse of their data for the purposes of this research.
排除标准
- •Patient or parents having expressed their opposition to participating in the study.
结局指标
主要结局
Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN
时间窗: Up to 2 years
The non-inferiority of LEVETIRCETAM in comparison with PHENYTOIN is based on a composite primary endpoint consisting of the total duration of the seizure, the need for another antiepileptic treatment to resolve the seizure or recurrence within 24 hours. following the start of treatment for a new status epilepticus and the total duration of hospitalization. The need for another antiepileptic drug or recurrence is a binary variable with presence (= yes = 1) or absence (= no = 0). The total duration of the crisis is expressed in minutes, and corresponds to the interval between the identification of the event and the objectification of its cessation. The total duration of hospitalization is expressed in days, and corresponds to the duration between the first day of hospitalization (regardless of the location) and the day of discharge (regardless of the department).
次要结局
未报告次要终点