Clinical Precision and In-use Analyte Stability Study for Four (4) Parameters in Neonate Arterial Blood for PICO70 and SafePICO

NCT06702267 | Completed

• 1 other identifier: DC-086959
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to determine the total (within-lot and between lots) precision for four (4) parameters (pO2, tBil, ctHb and FHbF) in neonatal arterial blood. Furthermore, the objective is to determine the analyte in-use stability for each blood gas syringe in arterial blood for neonatal blood parameters. In-use analyte stability in neonatal arterial blood in PICO70 and safePICO for each parameter, measuring at four testing timepoints. It is expected that he precision performance of each parameter is equal to or within the acceptance criteria/performance claim. The in-use analyte stability measured at four testing timepoint is within the acceptance criteria.

Conditions

Measure the Precision and Stability in PICO70 and SafePICO Over Time

Outcome Measures

Primary Outcomes (2)

• In-use analyte stability in neonatal arterial blood in PICO70 and safePICO for each parameter, measuring at four testing timepoints.

  Furthermore, the objective is to determine the analyte in-use stability for each blood gas syringe in arterial blood for neonatal blood parameters.

  One subject delivers blood samples to be measured over time (45 min.)

• Precision in neonatal arterial blood in PICO70 and safePICO for each parameter.

  The objective is to determine the total (within-lot and between lots) precision for four (4) parameters (pO2, tBil, ctHb and FHbF) in neonatal arterial blood.

  One subject delivers blood samples to be measured over time (45 min.)

Study Arms (1)

cord/placenta from women given birth

One single group is included in the study for the investigation of the PICO70 and safePICO syringes.

Device: arterial blood samplers with needles PICO70 and safePICO syringes.

Interventions

arterial blood samplers with needles PICO70 and safePICO syringes. DEVICE

PICO70 is a self-filling syringe for sample volumes in the range of 0.3-1.5 mL. All syringes are delivered with needle cube for safe needle disposal and a standard tip cap to reduce the risk of blood contact during blood mixing and sample transportation. safePICO is a more advanced group of syringes based on the PICO70 family. They contain a gold coated magnetic steel ball facilitating automatic mixing of the blood when being used with the Radiometer ABL 90 with mixing module. The safePICO is a self-filling syringe covering a volume range of 0.7-1.5 mL and includes a vented safe tip cap (VTC), which simplifies removal of air bubbles and avoid the operator to get in contact with the blood, after attachment to the syringe. Some variants of safePICO are delivered with a needle shield device (NSD) to ensure safe removal of the needle.

cord/placenta from women given birth

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Subject must be pregnant and at least 37 weeks of gestation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant adult women 18 years of age or older admitted to the maternity ward to give birth vaginally or to undergo cesarian section after 37 weeks of gestation. The pregnant woman gives informed consent to ensure accept of the cord/placenta sample collection and handling procedures. No study related procedures will be completed for the pregnant woman.

You may qualify if:

• Subject must be 18 years of age or older Subject must be pregnant and at least 37 weeks of gestation Subject must be admitted to the hospital maternity ward to give birth vaginally or to undergo cesarian section. Subject must be evaluated by the principal investigator or designee as suitable for the study according to the protocol

You may not qualify if:

• Subjects already enrolled in the study Subjects exposed to either Fluorescein dye or Patent Blue dye with last dose within 72 hours, should be excluded due to potential interference.

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected from cord/placenta and destroyed immediately after measurements.

Study Officials

• Maria Jeppegaard, PI

  External Coordinating Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: November 22, 2024
• Study Start: December 12, 2023
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 4 months in Q4 2023 - Q1 2024. Data will become available in Feb./March 2025

Locations

DK (1)