NCT02743988Unknown不适用
Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
University of Ulm1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Duration SpO2 < 80%
研究概览
简要总结
In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation < 80%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Days 至 42 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infant < 29 weeks gestation
- •at least 8 hypoxemic events during 8 hours
- •requires supplemental oxygen to achieve high SpO2 target range
- •parental consent given
排除标准
- •congenital life-threatening malformation
- •fatal outcome expected
- •airway malformation
- •higher grade intraventricular bleeding (grade III or IV according to LA Papile)
- •posthaemorrhagic hydrocephalus
- •life-threatening disease at the time of study entry
研究组 & 干预措施
Low target range
Experimental
Low oxygen saturation target range: SpO2 85-89%
干预措施: Oxygen (Drug)
High target range
Active Comparator
High oxygen saturation target range: SpO2 91-95%
干预措施: Oxygen (Drug)
结局指标
主要结局
Duration SpO2 < 80%
时间窗: during 16 hours of measurement
次要结局
- Cerebral tissue oxygen saturation as measured by NIRS(during 16 hours of measurement)
- Arterial SpO2 as measured by pulse oxymetry(during 16 hours of measurement)
- Heart rate as measured by ECG(during 16 hours of measurement)
- cerebral and visceral fractional oxygen extraction as measured by NIRS(during 16 hours of measurement)
- Cardiac output as measured by Cardiovelocimetry(during 16 hours of measurement)
- Number of hypoxemic and / or bradycardic events(during 16 hours of measurement)
- Visceral tissue oxygen saturation as measured by NIRS(during 16 hours of measurement)
研究者
Manuel Schmid
MD
University of Ulm
研究点 (1)
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