ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

Description

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.

Conditions

Congenital Heart Disease

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Study Overview

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Study Details

Study overview

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.

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

ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

Condition
Congenital Heart Disease
Intervention / Treatment

-

Contacts and Locations

Saint Louis

St Louis Children's Hospital, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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).

Ages Eligible for Study

1 Day to 28 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Radiometer Medical ApS,

Dennis Dietzen, PhD, PRINCIPAL_INVESTIGATOR, St. Louis Children's Hospital

Study Record Dates

2024-01-30