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Transcutaneous Bilirubinometry in Neonates With Bilicare System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 22, 2015
First Posted Date  ICMJE February 26, 2015
Results First Submitted Date  ICMJE August 13, 2015
Results First Posted Date  ICMJE September 11, 2015
Last Update Posted Date September 11, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2015)
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) ]
BiliCare TcB Result compared to TSB result
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2015)
BiliCare TcB Result compared to competitive device result [ Time Frame: 30 minutes within taking the blood draw for TSB (either before or after the blood draw) ]
BiliCare TcB Result compared to competitive device result
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcutaneous Bilirubinometry in Neonates With Bilicare System
Official Title  ICMJE Transcutaneous Bilirubinometry in Neonates With Bilicare System
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Intervention  ICMJE Device: BiliCare

Three non invasive measurements of TcB:

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

Study Arms  ICMJE BiliCare

Three non invasive measurements of TcB:

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

Intervention: Device: BiliCare
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2015)
103
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2015)
100
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02372058
Other Study ID Numbers  ICMJE 10002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerium Medical
Study Sponsor  ICMJE Gerium Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Schutzman, MD Einstein Medical Center
PRS Account Gerium Medical
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP