Recurrent Crying Spells in Cerebral Palsy With Spastic Quadriparesis - A Crossover Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change from baseline cry duration in seconds over a 10-day period while on placebo.
研究概览
简要总结
This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.
详细描述
This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent Crying Spells in Cerebral Palsy with Spastic Quadriparesis.
- •Age range 0-12 years.
排除标准
- •Crying due to known causes (like hunger, sleep, food intolerance etc.),
- •Crying that responded to routine management (changes in food or feeding techniques, anticolic, analgesics),
- •Fever of ≥100.4ºF (38ºC),
- •The infant refuses to eat or drink for more than a few hours, vomits excessively, has bloody stools, or has a change in behavior (lethargy or decreased responsiveness).
- •Worst ever crying occurring for the first time
- •Respiratory, renal and hepatic diseases,
- •Progressive encephalopathies,
- •Received Baclofen in the previous 30 days
研究组 & 干预措施
Baclofen
The starting dose was 0.75 mg/kg in four divided doses daily and was cautiously increased at three-day intervals until crying subsided or symptoms of over dosage or side effects appeared. The usual maximum dose was two mg/kg in four divided doses daily.
干预措施: Baclofen (Drug)
placebo
Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline cry duration in seconds over a 10-day period while on placebo.
时间窗: 11th to 20th day and 51st day to 60th day
Cry duration in seconds over a 10-day period while on placebo was compared to that of Baclofen.
次要结局
未报告次要终点
研究者
Dr.Nagabhushana Rao Potharaju
Principal Investigator
Sathbhavana Brain Clinic