Bilistick Point-of-care System 2.0 Bilirubin Validation

NCT06058910 | Completed

• 1 other identifier: KHN-2023-109
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Bilistick System 2.0 point-of-care testing device 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.

Also known as: Bilistick point-of-care testing device

Newborn

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kettering Health Network: lead
• Bilimetrix s.r.l.: collaborator

Study Sites (1)

Kettering Health Main Campus

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Kernicterus; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Erythroblastosis, Fetal; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Immune System Diseases; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia, Neonatal

Study Officials

• Jonathan D Toot, MD

  Kettering Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: February 1, 2024
• Primary Completion: June 16, 2024
• Study Completion: September 9, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)