ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 612
- 试验地点
- 2
- 主要终点
- Slope, R^2 and bias
研究概览
简要总结
The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial, venous, and capillary whole blood for ctBil and FHbF in a Point of Care (POC) setting.
详细描述
The main question it aims to answer is:
To quantify the relationship using comparison measurement from the same sample between the test device and the predicate device within the reportable range for ctBil and FHbF in heparinized arterial and venous neonatal whole blood in syringe measuring mode (S65, SP65) and heparinized mixed venous/arterial whole blood samples in capillary measuring mode (C65).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following are the inclusion criteria for the neonatal subjects:
- •The age of the subject must be ≤28 days.
- •Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.
- •Subjects having a sample drawn as part of standard of care that meets the requirements for samples in this study.
- •The following are the inclusion criteria for the subjects providing placenta for cord blood:
- •Delivery ≥38 weeks of gestation.
排除标准
- •The following are the exclusion criteria for the neonatal subjects:
- •Subject who has already provided successful results from arterial, venous and mixed venous/arterial samples, to cover both syringe modes and the capillary mode and parameters.
- •Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.
- •Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).
- •The following are the exclusion criteria for the subjects providing placenta for cord blood:
- •Subjects positive of HIV or Hepatitis C
结局指标
主要结局
Slope, R^2 and bias
时间窗: 6-9 months
Slope, R\^2 and bias at medical decision points for each combination of modes and sample type
次要结局
未报告次要终点