RECRUITING

ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-17

Study Completion:2024-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06078943

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.

Ages Eligible for Study:1 Day to 28 Days

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Study Contact

Lone Pedersen, PhD

CONTACT

+4528989640

lone.graasboljuulpedersen@radiometer.dk

Principal Investigator

Dennis Dietzen, PhD

PRINCIPAL_INVESTIGATOR

St. Louis Children's Hospital

Study Locations (Sites)

St Louis Children's Hospital

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Radiometer Medical ApS

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-17

Study Completion Date2024-01-30

Study Record Updates

Study Start Date2023-03-17

Study Completion Date2024-01-30

Terms related to this study

Keywords Provided by Researchers

Blood gas

Additional Relevant MeSH Terms

Congenital Heart Disease