ABL90 FLEX PLUS Method Comparison Neonatal Capillary

Completed · Not applicable

Conditions studied: Method Comparison for ABL90 FLEX PLUS in Neonatal Subjects

In brief

The study is intended to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal capillary whole blood for ctBil and FHbF in a POC setting

Key facts

Study ID

NCT07051278

Run by

Radiometer Medical ApS

People needed

129

Starts

2023-11-10

Expected to finish

2025-01-31

Last updated by the study team

2025-07-04

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent collected from legal representative able to understand information given and willing and able to voluntary give their consent to participate in this study.
• The age of the subject must be ≤28 days.
• Subject evaluated as suitable according to the protocol to enrol in the study by principal investigator or designee

You may not qualify if…

• Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
• Subject, who has an invalid written informed consent or has withdrawn consent.
• Subject who has already provided successful results from capillary samples, to cover both parameters.
• Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.

Where it is running

• Albert Einstein College of Medicine — The Bronx, New York, United States
• Duke University — Durham, North Carolina, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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