Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
研究概览
简要总结
The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at < 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants < 30 weeks estimated gestational age
排除标准
- •Infants with major congenital anomalies
- •Infants >34 weeks post-menstrual age
结局指标
主要结局
Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
时间窗: Up to a maximum of 14 data collection times
Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.
次要结局
- Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.(Up to a maximum of 14 data collection times)