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Transcutaneous Bilirubinometry in Neonates With Bilicare System

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ClinicalTrials.gov Identifier: NCT02372058
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Gerium Medical

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

Condition or disease Intervention/treatment Phase
We Will Focus on Assessing the Clinical Performance of the BiliCare Device Device: BiliCare Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Transcutaneous Bilirubinometry in Neonates With Bilicare System
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015
Arms and Interventions
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Arm Intervention/treatment
BiliCare

Three non invasive measurements of TcB:

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

 Device: BiliCare

Three non invasive measurements of TcB:

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


Outcome Measures
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Primary Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372058


Locations
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United States, Pennsylvania
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Gerium Medical
Investigators
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Principal Investigator: David Schutzman, MD Einstein Medical Center
More Information
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Responsible Party: Gerium Medical
ClinicalTrials.gov Identifier: NCT02372058    
Other Study ID Numbers: 10002
First Posted: February 26, 2015    Key Record Dates
Results First Posted: September 11, 2015
Last Update Posted: September 11, 2015
Last Verified: August 2015