Bilistick Point-of-care System 2.0 Bilirubin Validation

Bilistick Point-of-care System 2.0 Bilirubin Validation Utilizing Blood Samples Collected in Pediatric Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Kernicterus; Point-of-Care Testing; Neonatal Screening; Newborn Jaundice
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jonathan D Toot, MD; Phone Number: (937) 558-3900; Email: jonathan.toot@ketteringhealth.org

Study Locations

• United States
  • Ohio
    • Kettering, Ohio, United States, 45429
      • Recruiting
      • Kettering Health Main Campus
      • Contact: Jonathan Toot, MD PhD; Phone Number: 937-558-3900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Bilistick point-of-care testing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilistick Total Bilirubin	Measurement of total bilirubin (milligram/deciliter) using the Bilistick 2.0 point-of-care system	birth through 2-weeks of age
Reference Clinical Total Bilirubin	Measurement of total bilirubin (milligram/deciliter) using standard laboratory clinical instrument sample analysis	birth through 2-weeks of age

Collaborators and Investigators

• Sponsor: Kettering Health Network
• Collaborators: Bilimetrix s.r.l.
• Investigators: Principal Investigator: Jonathan D Toot, MD, Kettering Health

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Hematologic Diseases; Infant, Newborn, Diseases; Skin Manifestations; Brain Diseases, Metabolic; Hyperbilirubinemia; Erythroblastosis, Fetal; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal; Kernicterus
• Other Study ID Numbers: KHN-2023-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No