Transcutaneous Bilirubinometry in Neonates With Bilicare System

NCT ID: NCT02372058

Last Updated: 2015-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-03-31

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

Three non invasive measurements of TcB:

Two measurements with the BiliCare device and one measurement with a competitive FDA approved device

Group Type: OTHER

BiliCare

Intervention Type: DEVICE

Three non invasive measurements of TcB:

Two measurements with the BiliCare device and one measurement with a competitive FDA approved device

Interventions

BiliCare

Three non invasive measurements of TcB:

Two measurements with the BiliCare device and one measurement with a competitive FDA approved device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gerium Medical

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Schutzman, MD

Role: PRINCIPAL_INVESTIGATOR

Einstein Medical Center

Locations

Einstein Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

10002

Identifier Type: -

Identifier Source: org_study_id