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Completed

NCT Number: NCT02372071

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Center

Jerusalem, 91120, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed parental informed consent
  • Gestational Age >=24 weeks

Exclusion criteria

  • Less than 24 weeks of pregnancy at delivery
  • Bruising at the point of measurement on both ears
  • Birthmarks at the point of measurement on both ears
  • Hematomas at the point of measurement on both ears
  • Excessive Hairiness at the point of measurement on both ears
  • Neonate is during Phototherapy or has been exposed to phototherapy treatment during the last six hours

Treatment and study plan

BiliCare

Device

Two measurements with the BiliCare device

Primary outcomes

  1. BiliCare TcB Result Compared to TSB Result

    Time frame: 30 minutes within taking the blood draw for TSB (either before or after the blood draw)

Sponsors and collaborators

Lead sponsor

Gerium Medical

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2015
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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