Brain Oxygenation in Extremely Preterm Infants-II
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Frequency of interventions used to address cerebral hypoxia
研究概览
简要总结
The Brain Oxygenation-II study (BOx-II) is a phase-II, multicenter, single-arm clinical trial evaluating interventions based on near-infrared spectroscopy (NIRS) monitoring of cerebral oxygen saturation in extremely premature infants. Enrolled infants will follow a treatment guideline to maintain cerebral oxygen saturation in a target range within the first 72 hours of life. The primary outcomes will include interventions used to maintain cerebral saturation in target range, rates of cerebral hypoxia and systemic hypoxia, and a composite of death or severe brain injury detected on term-equivalent magnetic resonance imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born with postmenstrual age less than 28 weeks
- •Signed informed consent
排除标准
- •Missing written parental informed consent
- •Decision not to conduct full intensive care support
- •No possibility to place cerebral NIRS oximeter within six hours after birth
- •Skin integrity insufficient to allow for sensor placement as deemed by a clinician
研究组 & 干预措施
Interventional Arm
All infants will undergo non-invasive NIRS monitoring of cerebral oxygen saturation and will have algorithm-driven clinical interventions to maintain cerebral saturation within target range during the first 72 hours of life.
干预措施: Intervention for cerebral hypoxia (Other)
结局指标
主要结局
Frequency of interventions used to address cerebral hypoxia
时间窗: From birth until 72 hours of life
Frequency of specific interventions chosen to address cerebral hypoxia
次要结局
- Rates of death or severe brain injury(36-42 weeks corrected gestational age)
- Rates of cerebral hypoxia and systemic hypoxia(From birth until 72 hours of life)
研究者
Valerie Chock, M.D., M.S. Epi
Associate Professor of Pediatrics
Stanford University