Bilistick Point-of-care System 2.0 Bilirubin Validation

Neonatal Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058910
• Other study ID #: KHN-2023-109
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Kettering Health Network
• Contact: Jonathan D Toot, MD
• Phone: (937) 558-3900
• Email: jonathan.toot[@]ketteringhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal
• Kernicterus
• Neonatal Screening
• Point-of-Care Testing

Intervention

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.

Locations

Country	Name	City	State
United States	Kettering Health Main Campus	Kettering	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kettering Health Network	Bilimetrix s.r.l.

Country where clinical trial is conducted

United States, 

Outcome

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