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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
NIRS
Experimental
Children who undergo NIRS
干预措施: Near Infrared Spectroscopy (NIRS) (Device)
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
研究点 (1)
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