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临床试验/NCT00929045
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

University of Virginia0 个研究点目标入组 8 人开始时间: 2007年7月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

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