Safeguarding the Brains of Our Smallest Children - a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- change of medical management elicited by cerebral oxygenation out of range
研究概览
简要总结
Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age at birth less than 28 completed weeks
- •cerebral oximeter in place at 3 hours after birth
排除标准
- •decision not to provide full life support
研究组 & 干预措施
cerebral oximetry + treatment guideline
Cerebral oximetry applied as soon as possible after birth and continued until 72 hours of life Clinical staff administer the routine medical management according to local practice as well as respond to out-of-range values with the help of the treatment guideline
干预措施: cerebral oximeter (Device)
结局指标
主要结局
change of medical management elicited by cerebral oxygenation out of range
时间窗: 0-72 hours of life
Recording of the type of change of management as defined by the treatment guideline
次要结局
- Adverse device effects(0-72 hours)
- burden of hypo-and hyperoxia(0-72 hours)
研究者
Gorm Greisen
professor,head of department
Rigshospitalet, Denmark