ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06078943

Enrollment

612

Registered

2023-10-12

Start date

2023-03-17

Completion date

2024-01-30

Last updated

2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

Blood gas

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 Point of Care (POC) setting.

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 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).

Interventions

DEVICEmethod comparison

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactLone Pedersen, PhD

lone.graasboljuulpedersen@radiometer.dk+4528989640

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026