Transcutaneous Bilirubinometry in Neonates With Bilicare System

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

Official title:

Transcutaneous Bilirubinometry in Neonates With Bilicare System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372058
• Other study ID #: 10002
• Status: Completed
• Phase: N/A
• First received: February 22, 2015
• Last updated: August 13, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Gerium Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

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

Intervention

Device:
• BiliCare
Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device

Locations

Country	Name	City	State
United States	Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Gerium Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BiliCare TcB Result Compared to TSB Result		30 minutes within taking the blood draw for TSB (either before or after the blood draw)	No