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.

Study Overview

• Status: Completed
• Conditions: We Will Focus on Assessing the Clinical Performance of the BiliCare Device
• Intervention / Treatment: Device: BiliCare

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: BiliCare; Two measurements with the BiliCare device	Device: BiliCare; Two measurements with the BiliCare device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Gerium Medical
• Investigators: Principal Investigator: Benjamin Bar-Oz, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 22, 2015
• First Submitted That Met QC Criteria: February 22, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): September 11, 2015
• Last Update Submitted That Met QC Criteria: August 13, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 10003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No