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Bilistick Point-of-care System 2.0 Bilirubin Validation

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ClinicalTrials.gov Identifier: NCT06058910
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : February 7, 2024
Sponsor:
Collaborator:
Bilimetrix s.r.l.
Information provided by (Responsible Party):
Jonathan Toot, Kettering Health Network

Study Description
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Brief Summary:
This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected for both a diagnostic reference device and Bilistick System 2.0 point-of-care device. Whole blood samples collected from male or female newborns (<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device with current laboratory standards.

Condition or disease Intervention/treatment
Neonatal Screening Kernicterus Newborn Jaundice Point-of-Care Testing Diagnostic Test: Bilistick System 2.0 point-of-care testing device

Detailed Description:

The investigators propose a prospective diagnostic validation study comparing total bilirubin values measured under the reference clinical methodology to the point-of-care Bilistick System 2.0 testing device. During the routine standard-of-care whole blood sample collection (0.5 milliliters whole blood draw) for bilirubin assessments under reference clinical methodology, an additional 0.035 milliliters of whole blood will be collected (not to exceed more than 2 sample collections per week) for measurement in the point-of-care Bilistick System 2.0. The resulting Bilistick System 2.0 data will be recorded, but will not be entered in the patients' electronic medical records or used for any diagnostic or medical decision purposes.

Whole blood samples collected from male or female newborns (<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device will be included on study.

Consent forms will be Institutional Review Board (IRB)-approved and the parent or legal guardian of the participant will be asked to read the document. The investigator or delegated study staff will explain the research study to the parent or legal guardian of the participant and answer any questions that may arise. A verbal explanation will be provided to allow for the comprehension of the purposes, procedures, and potential risks of the study and rights of the research participant. The parent or legal guardian of the participant will be informed that participation is voluntary, they can withdraw at any time. Sufficient opportunity will be provided to carefully review the written consent form and ask questions prior to signing. The parent or legal guardian of the participant will sign the informed consent document prior to any procedures being done specifically for the study.

Since this study uses blood collected during an existing standard of care blood collection (i.e., there will be NO separate research-specific heel stick) this study poses no additional risk and parental permission will be required by only one parent.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Bilistick Point-of-care System 2.0 Bilirubin Validation Utilizing Blood Samples Collected in Pediatric Patients
Actual Study Start Date : February 1, 2024
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Newborn
This study will include newborn pediatric patients under 2-weeks of age who are necessary to conduct this study and are representative of the target population for use with this device.
 Diagnostic Test: Bilistick System 2.0 point-of-care testing device
The routine standard-of-care blood sample collection involves a 0.5 milliliter whole blood draw by the heel stick method for bilirubin assessments under current reference clinical methodology for total bilirubin. An additional 0.035 milliliter of whole blood will be collected for measurement in the point-of-care Bilistick System 2.0 (Bilistick point-of-care testing device). The resulting Bilistick System 2.0 data (i.e., total bilirubin) will be recorded, but will not be entered into the patients' electronic medical records or used for any diagnostic or medical decision purposes.
Other Name: Bilistick point-of-care testing device


Outcome Measures
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Primary Outcome Measures :
  1. Bilistick Total Bilirubin [ Time Frame: birth through 2-weeks of age ]
    Measurement of total bilirubin (milligram/deciliter) using the Bilistick 2.0 point-of-care system

  2. Reference Clinical Total Bilirubin [ Time Frame: birth through 2-weeks of age ]
    Measurement of total bilirubin (milligram/deciliter) using standard laboratory clinical instrument sample analysis


Eligibility Criteria
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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will include newborn pediatric patients under 2-weeks of age who are necessary to conduct this study and are representative of the target population for use with this device.
Criteria

Inclusion Criteria:

  • Participant is <2-weeks of age
  • Participant is inpatient hospital status
  • Participant undergoing routine blood sample collection for total serum bilirubin

Exclusion Criteria:

  • Parent or legal guardian of participant is Non-English speaking or reading
  • Parent or legal guardian of participant unable to give informed consent/parental permission
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06058910


Contacts
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Contact: Jonathan D Toot, MD (937) 558-3900 jonathan.toot@ketteringhealth.org

Locations
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United States, Ohio
Kettering Health Main Campus Recruiting
Kettering, Ohio, United States, 45429
Contact: Jonathan Toot, MD PhD    937-558-3900      
Sponsors and Collaborators
Kettering Health Network
Bilimetrix s.r.l.
Investigators
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Principal Investigator: Jonathan D Toot, MD Kettering Health
More Information
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Responsible Party: Jonathan Toot, Principal Investigator, Kettering Health Network
ClinicalTrials.gov Identifier: NCT06058910    
Other Study ID Numbers: KHN-2023-109
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kernicterus
Jaundice, Neonatal
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
 Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erythroblastosis, Fetal
Hematologic Diseases
Metabolic Diseases
Immune System Diseases