Transcutaneous Bilirubinometry in Neonates With Bilicare System

Not Applicable

Completed

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

Interventions: Device: BiliCare

Registration Number: NCT02372058

Lead Sponsor: Gerium Medical

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 103

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BiliCare	BiliCare	Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device

Primary Outcome Measures