Comparison of Alternative Non-invasive and Invasive Methods of Haemoglobin Measuring With the Gold Standard in Preterm and Term Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb
研究概览
简要总结
In this prospective study different methods of haemoglobin measurement in term and preterm neonates are compared with the gold standard. Non-invasive haemoglobin measurement with the Radical-7® (SpHb, Masimo®), point-of-care haemoglobin-measurement (HcHb, HemoCue@, Radiometer), blood-gas-analysis (BGAHb,ABL800®, Radiometer) are compared with haemoglobin measurement by an automated hematology analyzer (labHb, Siemens Advia®).
详细描述
Neonates admitted to neonatal intensive care unit or to a normal neonatal ward are enrolled in the study, if parents have given their written informed consent. Non-invasive SpHb measurements are recorded prior to routine venous sampling. Routine venous sampling includes labHb and BGAHb. Additionally HcHb is taken from the routine venous sampling (HcHbart/ven) and from an additionally capillary puncture of earlobe or heel (HcHbcap). Every neonate can participate in two measurements.
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
- 3 Days 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gender both
- •age limits minimum age 3 days of life maximum age 44 postmenstrual weeks
- •accepts no healthy volunteers
- •Inclusion Criteria:
- •written informed consent of the parents
排除标准
- •allergy against sensor patch
- •medical or psychological factors that inhibit a correct finazilation of the study
结局指标
主要结局
accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb
时间窗: through study completion, an average of 3 months
accuracy is assessed by Bland-Altman-method of comparison, by Root mean square error and by out of range
次要结局
- handling of the SpHb-device(through study completion, an average of 3 months)
- influence of weight and gender on accuracy of SpHb(through study completion, an average of 3 months)
- influence of PI (perfusion index) on accuracy of SpHb(through study completion, an average of 3 months)
- influence of concentration of HbF on accuracy of SpHb,BGAHb, HcHb(through study completion, an average of 3 months)
- influence of concentration of Hb on accuracy of SpHb,BGAHb, HcHb(through study completion, an average of 3 months)
- agreement of concentration of HbF of BGAHb with HbF of labHb(through study completion, an average of 3 months)
研究者
Dr. Eva Wittenmeier:MD
Principal Investigator
Johannes Gutenberg University Mainz