NCT02445417已完成不适用
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- EEG recorded
研究概览
简要总结
The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.
详细描述
There is a need for a reliable detector of birth asphyxia so that newborns with birth asphyxia can have timely and accurate diagnosis to receive therapeutic hypothermia within 6 hrs of life, which has been shown to significantly reduce deaths and improve long term developmental outcomes.
This study is designed to record EEG during birth transition through the first 10 minutes of life.
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
- 36 Weeks 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants
- •Signed Informed consent
排除标准
- •Known congenital anomalies
结局指标
主要结局
EEG recorded
时间窗: Birth to 10 minutes of life
May be up to 60 minutes if applicable
次要结局
- Successful adhesion of EES to skin(60 minutes of life)
- Skin irritation from EES or hydrogel electrodes(60 minutes of life)
研究者
M J Harbert
Director of Neonatal Neurology
Sharp HealthCare
研究点 (1)
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