The Effects of Treatment Guided by Cerebral Oximetry Monitoring on Renal Outcomes in Invasively Mechanically Ventilated Neonates: an Ancillary Study of the SafeBoosC-IIIv Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- composite outcome of death and acute kidney injury
研究概览
简要总结
Cerebral oximetry monitoring allows clinicians to optimize blood flow to the brain and oxygenation using the SafeBoosC treatment guideline. The guideline's interventions aims to stabilize blood pressure and oxygen levels.
As low blood pressure is a risk factor for the development of kidney injury, normalizing blood pressure may decrease the incidence of kidney injury in new-borns who are on ventilator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 28 weeks of gestation Invasively ventilated
排除标准
- •major anomalies
研究组 & 干预措施
Intervention Arm- Cerebral Oximetry + Treatment Guideline
Neonates who are ventilated in the NICU, in addition to standard care, will be monitored by cerebral oximetry. If the value falls below a certain threshold, the treatment guideline will be followed and corrective interventions undertaken.
干预措施: Intervention Arm- Cerebral Oximetry + Treatment Guideline (Other)
Control Arm- standard care
Neonates who are ventilated in the NICU will receive standard care only.
结局指标
主要结局
composite outcome of death and acute kidney injury
时间窗: From randomization to discharge up to 2months of life
composite outcome of death and acute kidney injury
次要结局
未报告次要终点