Status:
UNKNOWN
ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood
Lead Sponsor:
Radiometer Medical ApS
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
1-28 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2024
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT06078943
Start Date
March 17 2023
End Date
January 30 2024
Last Update
October 12 2023
Active Locations (1)
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1
St Louis Children's Hospital
St Louis, Missouri, United States, 63110