Targeted Cerebral Saturations in Extremely Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neurodevelopmental outcome
研究概览
简要总结
Implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral saturations (Csat) using near-infrared spectroscopy (NIRS). Infants will be randomized to a targeted cerebral saturation monitoring group with visible reading of Csat or to a control group with cerebral saturation monitoring, but with blinded Csat measures. Those in the targeted Csat group will follow a treatment guideline to maintain cerebral oxygenation in the target range. The primary outcome is neurodevelopmental outcome as determined by Bayley III cognitive scale score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors of neurodevelopmental outcome are blinded to targeted vs non-targeted monitoring
入排标准
- 年龄范围
- — 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very preterm infants with gestational age at least 23 weeks but less than 29 completed weeks
- •Less than 6 hours of age
排除标准
- •Skin integrity insufficient to allow placement of NIRS sensors
- •Decision not to provide full intensive care support
- •Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment
研究组 & 干预措施
Targeted Csats
Subjects randomized to the targeted Csat arm will have NIRS monitoring of cerebral saturations (Csat) and will have algorithm-driven clinical interventions to maintain Csat within target range in the first week of life.
干预措施: Clinical algorithm (Other)
Non-targeted Csats
Subjects randomized to the non-targeted Csat arm will have NIRS (near-infrared spectroscopy) monitoring of Csats, but Csat values will be obscured and not available to providers. These subjects will not have any algorithm-driven clinical interventions for Csat.
结局指标
主要结局
Neurodevelopmental outcome
时间窗: 22-26 months of age
Neurodevelopmental outcomes will be assessed using the cognitive component of the Bayley Scales of Infant Development-III at 22-26 months of age. Scores range from 55-145 with higher number representing a better neurodevelopmental outcome.
次要结局
- Death(from birth until hospital discharge, an average of 3 months.)
- Retinopathy of prematurity(from birth until hospital discharge, an average of 3 months.)
研究者
Valerie Chock, M.D., M.S. Epi
Principal Investigator
Stanford University