Bilistick Point-of-care System 2.0 Bilirubin Validation

Completed

• Conditions: Neonatal Screening; Kernicterus; Newborn Jaundice; Point-of-Care Testing
• Interventions: Diagnostic Test: Bilistick System 2.0 point-of-care testing device

• Registration Number: NCT06058910
• Lead Sponsor: Kettering Health Network

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.

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Study Start: 2024-02-01
• Primary Completion: 2024-06-16
• Study Completion: 2024-09-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newborn	Bilistick System 2.0 point-of-care testing device	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kettering Health Main Campus; 🇺🇸 Kettering, Ohio, United States