Bilistick Point-of-care System 2.0 Bilirubin Validation

NCT ID: NCT06058910

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-09-09

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.

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.

Conditions

Neonatal Screening; Kernicterus; Newborn Jaundice; Point-of-Care Testing

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Bilistick System 2.0 point-of-care testing device

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Bilistick point-of-care testing device

Eligibility 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

• Maximum Eligible Age: 2 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bilimetrix s.r.l.

OTHER

Sponsor Role: collaborator

Kettering Health Network

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Toot

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan D Toot, MD

Role: PRINCIPAL_INVESTIGATOR

Kettering Health

Locations

Kettering Health Main Campus

Kettering, Ohio, United States

Countries

United States

Other Identifiers

KHN-2023-109

Identifier Type: -

Identifier Source: org_study_id