Bilistick Point-of-care System 2.0 Bilirubin Validation

Completed

Conditions studied: Neonatal Screening, Kernicterus, Newborn Jaundice, Point-of-Care Testing

In brief

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.

Key facts

Study ID

NCT06058910

Run by

Kettering Health Network

People needed

80

Starts

2024-02-01

Expected to finish

2024-09-09

Last updated by the study team

2025-03-13

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Kettering Health Main Campus — Kettering, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.