ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Device: method comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Investigational Device<br>The test device in this clinical study is the ABL90 FLEX PLUS running SW3.5 MR2 manufactured by Radiometer Medical ApS The analyzer provides results for 17 parameters in 35 seconds using 65 µL heparinized whole blood. However, in this investigation only the data concerning the parameters ctBil and FHbF will be evaluated. | Device: method comparison<br>* to quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for all 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)<br>|
| Sham Comparator: Predicate device<br>The predicate device for this study is the unmodified device ABL90 FLEX PLUS (k160153) running software SW 3.1 MR7 including sensor casettes and solution packs versions corresponding to 2016. ABL90 FLEX PLUS SW 3.1 MR7, has been selected as the predicate device because it has the appropriate 510(k) clearance, and the intended use matches the ABL90 FLEX PLUS SW. SW3.5 MR2 device. | Device: method comparison<br>* to quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for all 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slope, R^2 and bias | Slope, R^2 and bias at medical decision points for each combination of modes and sample type | 6-9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood gas