Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cerebral metabolic rate of oxygen index (CMRO2i)
研究概览
简要总结
The timing and the indications for red blood cell (RBC) transfusions remain one of the most controversial topic in Neonatology. Indeed, biomarkers routinely used to discriminate between patients that will benefit from RBC transfusion appear insufficient. Tissue oxygenation could be useful to determine the need for transfusion.
This study aims to assess the effects of RBC transfusion on cerebral haemodynamics and oxygenation in neonates with a new hybrid optical device (BabyLux) integrating time-resolved spectroscopy (NIRS-TRS) and diffuse correlation spectroscopy (DCS).
It is hypothesized that cerebral blood flow decreases after RBC transfusion, whereas cerebral oxygenation and oxygen metabolism are unchanged.
详细描述
The BabyLux hybrid setup can determine the following parameters in the same tissue sample non-invasively and continuously with a high temporal resolution (0.1-0.2 Hz):
- Cerebral blood flow index (CBFi), i.e. an index that is proportional with CBF
- Concentration of oxyhaemoglobin (O2Hb)
- Concentration of deoxyhaemoglobin (dHb)
- Total haemoglobin concentration (tHb)
- Tissue oxygen saturation (rStO2)
- Cerebral metabolic rate of oxygen index (CMRO2i), i.e. an index that is proportional with CMRO2 Hence, the BabyLux device allows assessment of key parameters of cerebral haemodynamics and, in particular, to examine if the percentage change of cerebral metabolic rate for oxygen is close to the expected zero, as an external quality control of the separate NIRS parameters.
There are no studies on RBC transfusion in neonates evaluating cerebral haemodynamic utilizing DCS and TRS combined.
Hence, primary aim of this study is:
- to assess the effect of RBC transfusion on cerebral haemodynamics and oxygenation as measured by the Babylux device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Weeks 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RBC transfusion prescribed according to local NICU guidelines
- •Corrected age < 4 weeks corrected age
- •Signed informed consent
排除标准
- 未提供
结局指标
主要结局
Cerebral metabolic rate of oxygen index (CMRO2i)
时间窗: From immediately before to immediately after RBC transfusion
The change in an index proportional to CMRO2
次要结局
- Cerebral blood flow index (CBFi)(From immediately before to immediately after RBC transfusion)
- Differential path length factor (DPF)(From immediately before to immediately after RBC transfusion)
- Tissue oxygen saturation (rStO2)(From immediately before to immediately after RBC transfusion)
研究者
Gorm Greisen
professor
Rigshospitalet, Denmark