NCT00929045已完成早期 1 期
Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Recovery
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Neurocognitive changes following moderate/severe TBI
研究概览
简要总结
The purpose of this study is to look at the relationship between growth hormones, and recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with the body's ability to produce growth hormones. These hormones may be needed by the body for growth, mental development and sexual maturation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This is Phase II trial-subjects have already completed Phase I.
- •Traumatic brain injury (TBI).
- •Results of the blood work from Phase I shows that your growth hormone levels are low.
排除标准
- •Have not completed Phase I of the study.
研究组 & 干预措施
Growth Hormone
Experimental
干预措施: Growth Hormone Replacement (Drug)
结局指标
主要结局
Neurocognitive changes following moderate/severe TBI
时间窗: 1 year
次要结局
未报告次要终点
研究者
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