Clinical trial NCT02372071: Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
Official title: Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Lead sponsor: Gerium Medical
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: BiliCare TcB Result Compared to TSB Result
timeFrame: 30 minutes within taking the blood draw for TSB (either before or after the blood draw)
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Benjamin Bar-Oz, MD
role: PRINCIPAL_INVESTIGATOR
References: