Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
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 [1].
 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.
Inclusion Criteria:

 1. Signed parental informed consent

 2. Gestational Age >=24 weeks

 Exclusion Criteria:

 1. Less than 24 weeks of pregnancy at delivery

 2. Bruising at the point of measurement on both ears

 3. Birthmarks at the point of measurement on both ears

 4. Hematomas at the point of measurement on both ears

 5. Excessive Hairiness at the point of measurement on both ears

 6. Neonate is during Phototherapy or has been exposed to phototherapy treatment during
 the last six hours