Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test

NCT ID: NCT02372071

Last Updated: 2015-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-06-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

BiliCare

Two measurements with the BiliCare device

Group Type: OTHER

BiliCare

Intervention Type: DEVICE

Two measurements with the BiliCare device

Interventions

BiliCare

Two measurements with the BiliCare device

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gerium Medical

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Bar-Oz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

10003

Identifier Type: -

Identifier Source: org_study_id