ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood
ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lone Pedersen, PhD
- Phone Number: +4528989640
- Email: lone.graasboljuulpedersen@radiometer.dk
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- St Louis Children's Hospital
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Contact:
- Dennis Dietzen, PhD, DABCC, FAACC
- Phone Number: 314-362-6586
- Email: dietzen_d@wustl.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 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).
The following are the exclusion criteria for the subjects providing placenta for cord blood:
• Subjects positive of HIV or Hepatitis C
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Investigational Device
The test device in this clinical study is the ABL90 FLEX PLUS running SW3.5 MR2 manufactured by Radiometer Medical ApS The analyzer provides results for 17 parameters in 35 seconds using 65 µL heparinized whole blood.
However, in this investigation only the data concerning the parameters ctBil and FHbF will be evaluated.
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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)
|
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Sham Comparator: Predicate device
The predicate device for this study is the unmodified device ABL90 FLEX PLUS (k160153) running software SW 3.1 MR7 including sensor casettes and solution packs versions corresponding to 2016. ABL90 FLEX PLUS SW 3.1 MR7, has been selected as the predicate device because it has the appropriate 510(k) clearance, and the intended use matches the ABL90 FLEX PLUS SW. SW3.5 MR2 device. |
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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Slope, R^2 and bias
Time Frame: 6-9 months
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Slope, R^2 and bias at medical decision points for each combination of modes and sample type
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6-9 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dennis Dietzen, PhD, St. Louis Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC-083185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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