NCT01598259终止2 期
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- sleep
研究概览
简要总结
The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodology specific for burn patients that accurately screens for the presence of intrinsic dyssomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of burn injury
- •Scheduled for an elective surgical procedure
- •5 - 22 years of age, inclusive
排除标准
- •History of anoxic brain injury
- •History of head injury within the last year
- •Pre-existing seizure disorder
- •Pre-existing neurological disorder
- •Pre-existing blindness
- •Known hypersensitivity to melatonin
- •Anticoagulant use or aspirin therapy
- •Antihypertensive medication use
- •Diabetes mellitus or other endocrine disorders
- •Autoimmune disorders
- •Schizophrenia
- •Inability to access internet
- •Intellectual disability or inability to follow directions
研究组 & 干预措施
melatonin
Experimental
Subjects will receive melatonin
干预措施: Melatonin (Drug)
placebo
Placebo Comparator
干预措施: placebo (Other)
结局指标
主要结局
sleep
时间窗: 3 years
Measure sleep parameters via polysomnography, actigraphy and urinary melatonin
次要结局
未报告次要终点
研究者
Michele Gottschlich
Research Scientist
Shriners Hospitals for Children
研究点 (1)
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