Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth - a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Change of cerebral tissue oxygen saturation (crSO2) level
研究概览
简要总结
Especially in neonates non-invasive methods are required for monitoring the complex changes during immediate transition after birth to improve assessment of neonate and eventually resuscitation. During this period especially, the brain is vulnerable and monitoring the brain and possible influencing factors of cerebral oxygenation and perfusion are of great interest. To initiate and guide therapies based on cerebral oxygenation, it is important to define reference ranges.
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
- 0 Minutes 至 15 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term and preterm neonates observed routinely at the resuscitation desk
- •Decision to conduct full life support
- •Written informed consent
- •Neonates who require no respiratory or medical support
排除标准
- •No decision to conduct full life Support
- •No written informed consent
- •Congenital malformation
- •Neonates who require respiratory and/ or medical support
结局指标
主要结局
Change of cerebral tissue oxygen saturation (crSO2) level
时间窗: At each minute from minute 1 to minute 15 after birth
To measure cerebral oxygenation with Root (O3 regional oxymetry, Masimo, USA) non-invasively and continuously during the first 15 minutes after birth and establish the reference ranges in term and preterm neonates.
次要结局
未报告次要终点