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临床试验/NCT00795119
NCT00795119已完成不适用

A Clinical Assessment of the Reliability of Near Infrared Spectroscopy for the Detection of Intracranial Hemorrhage in Young Children

IWK Health Centre2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
2
主要终点
Sensitivity of NIRS

研究概览

简要总结

To diagnose bleeding inside the head, children need to have a CT Scan or MRI of their heads. Not all doctors order these though, especially when there is no history of injury or when children don't look too sick. Unfortunately, this means that some children's bleeding doesn't get diagnosed as early as it could. This study wants to find a way to detect bleeding inside the head without using a CT scan or MRI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
— 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All children under 3 years of age who undergo a CT of the head or MRI of the head.

排除标准

  • Lack of parental consent
  • Neurosurgical intervention between CT/MRI and NIRS scanning.
  • Scalp hematoma

结局指标

主要结局

Sensitivity of NIRS

时间窗: Study conclusion

次要结局

  • specificity of NIRS, positive/negative predictive value(Study conclusion)

研究者

申办方类型
Other

研究点 (2)

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