CompletedNot Applicable

Bilistick Point-of-care System 2.0 Bilirubin Validation

United States80 participantsStarted 2024-02-01

Plain-language 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.

Who can participate

Age range2 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Bilistick Total Bilirubin

Timeframe: birth through 2-weeks of age

Reference Clinical Total Bilirubin

Timeframe: birth through 2-weeks of age

Trial details

NCT IDNCT06058910

SponsorKettering Health Network

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-16

View on ClinicalTrials.gov More Neonatal Screening trials