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
- 2
- 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
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