NCT03631901已完成4 期
Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- recurrence of febrile seizures during febrile illness
研究概览
简要总结
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.
详细描述
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 months to 5 yrs .
- •Simple febrile seizures
排除标准
- •Complex febrile seizures
- •Child with history of neonatal seizure.
- •Afebrile seizures.
- •History of anticonvulsive therapy.
- •Children suffering from epilepsy.
- •Children with abnormal EEG.
- •Children with abnormal neurological examination.
- •Positive family history of epilepsy.
研究组 & 干预措施
Melatonin
Active Comparator
melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.
干预措施: oral melatonin (Drug)
Diazepam
Active Comparator
oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.
干预措施: oral diazepam (Drug)
结局指标
主要结局
recurrence of febrile seizures during febrile illness
时间窗: 6 months
次要结局
- side effect of medications reported in children(6 months)
研究者
Amira Hamed Darwish
Professor of pediatrics and Principal Investigator
Tanta University
研究点 (1)
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