Effect of Melatonin Supplementation on Sleep and Health of Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in growth
研究概览
简要总结
The present study was prospective uncontrolled, single-armed and un-blinded study. Held in the Pediatric neurology clinic, Children's hospital l, Faculty of Medicine, Ain Shams University from June 2016 to June 2018 of 24 months timeframe. All cerebral palsy (CP) patients following up in Pediatric neurology clinic aged between 2 and 12 years. Melatonin given for 3 months. Anthropmetric measures, gastroeintestinal symptoms, Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months.
详细描述
A prospective, cohort study conducted in Pediatric Neurology Clinic, Children's Hospital, Faculty of Medicine, Ain Shams University. Forty children with sCP with sleep and seizure problems, aged 2-12 years were enrolled. The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months. Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months. The ethical approval number is (FMASU MD 202/2016).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cerebral palsy children with sleep problem and seizure disorder,
- •aged 2 - 12 years
排除标准
- •any auditory and peripheral visual impairments
研究组 & 干预措施
Cerebral palsy
Not included
干预措施: Melatonin 3 mg (Drug)
结局指标
主要结局
Improvement in growth
时间窗: 3-months
response to melatonin in improvement of growth
Decrease in total Children's sleep habits questionnaire score
时间窗: after 3-months
response to melatonin as decrease in total sleep score
次要结局
未报告次要终点
研究者
Sahar M.A. Hassanein, MD
Professor of Pediatrics
Ain Shams University