Transcutaneous Bilirubinometry in Neonates With Bilicare System

Study Overview
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Brief Summary
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The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the gold standard bilirubin tests.

Detailed Description
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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.

Official Title
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Transcutaneous Bilirubinometry in Neonates With Bilicare System

Conditions
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We Will Focus on Assessing the Clinical Performance of the BiliCare Device

Intervention / Treatment
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* Device: BiliCare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parental informed consent Male and female newborns with a GA ≥ 35 wks Enrollment at age > 6 hrs until neonatal discharge. Pre-phototherapy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BiliCare<br>Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device | Device: BiliCare<br>* Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BiliCare TcB Result Compared to TSB Result |  | 30 minutes within taking the blood draw for TSB (either before or after the blood draw) |