The primary objective of this study is to define the performance evaluation of BiliCare TcB
device to the "gold standard" bilirubin tests.
Neonatal hyperbilirubinemia or newborn jaundice impacts over 85% of all newborns .
Regardless of the mechanism, excessive hyperbilirubinemia has been traditionally treated
with phototherapy to minimize any probable risk of developing bilirubin-induced
neurotoxicity. However, earlier and more recent data suggest that pre-discharge bilirubin
screening for risk of significant hyperbilirubinemia, whether due to a rapid bilirubin
production or an earlier age of onset, has impacted the guidelines for clinical use of
phototherapy [1, 2]. In this study, we plan to test the performance of a novel
transcutaneous device (BiliCareTM) first for screening for bilirubin levels at postnatal age
of 6 to 48 hrs; and possibly also, to substitute the use of this measurement for total
plasma/serum bilirubin (TB). This device applies a novel light transmission technology that
has the potential to measure bilirubin as a point-of-care test in the subcutaneous tissue,
and then uses an internal algorithm to calculate bilirubin levels in the skin. In this
proposalstudy, we will to assess the clinical performance of the BiliCare by correlating
measurements made by this device to near-concurrent measure of total plasma/serum bilirubin
at normative ranges (mean, median, range and inter-quartile ranges ) for all term and
late-preterm newborns (including those who are at-risk for jaundice and / or being
administered with phototherapy) born to families of diverse race and ethnic backgrounds.
- Parental informed consent
- Male and female newborns with a GA ≥ 35 wks
- Enrollment at age > 6 hrs until neonatal discharge.
- Infants requiring respiratory assistance (such as mechanical ventilation)
- Severe or life-threatening congenital anomalies
- Hematomas at the point of measurement on both ears
- Neonates undergone blood transfusion