NCT03835039终止不适用
The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Neurodevelopment at 2 years of age
研究概览
简要总结
A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with diagnosis at birth of HIE
排除标准
- 未提供
结局指标
主要结局
Neurodevelopment at 2 years of age
时间窗: 2 years
Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.
MRI findings of encephalopathy
时间窗: 6 days
MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.
次要结局
未报告次要终点
研究者
研究点 (1)
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