Point-of-Care System for Determination of Bilirubin Capacity in Neonates
Point-of-Care System for Determination of Bilirubin Capacity in Neonates
The aims of this project are to validate the performance of the miniaturized and modernized
 hematofluorometer that measures bilirubin capacity into a product and is suitable for
 operation in various point of care environments when encountering confounding direct
 bilirubin, to complete the development of easy to use sample handling disposables, and to
 verify the performance of the system for samples from a specified population of neonates.
Inclusion Criteria:

 -  Subjects must meet all of the following inclusion criteria to be considered eligible
 for study enrollment soon after birth or re-admission (for phototherapy):

 -  Parental informed consent

 -  Male and female newborns with a GA ≥ 28 wks with a birthweight ≥ 1000 g including
 infants with GA ≥ 35 wks with a birthweight ≥ 2500 g who are clinically deemed at
 risk.

 -  Enrollment at age less than 14 days and more than 6h

 Exclusion Criteria:

 -  None.