Status:
COMPLETED
Bilistick Point-of-care System 2.0 Bilirubin Validation
Lead Sponsor:
Kettering Health Network
Collaborating Sponsors:
Bilimetrix s.r.l.
Conditions:
Neonatal Screening
Kernicterus
Eligibility:
All Genders
Up to 2 years
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-c...
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...
Eligibility Criteria
Inclusion
- Participant is \<2-weeks of age
- Participant is inpatient hospital status
- Participant undergoing routine blood sample collection for total serum bilirubin
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06058910
Start Date
February 1 2024
End Date
September 9 2024
Last Update
March 13 2025
Active Locations (1)
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1
Kettering Health Main Campus
Kettering, Ohio, United States, 45429