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The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiliCare | Other | Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiliCare | Device | Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device |
|
| Measure | Description | Time Frame |
|---|---|---|
| BiliCare TcB Result Compared to TSB Result | 30 minutes within taking the blood draw for TSB (either before or after the blood draw) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Schutzman, MD | Einstein Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Late Preterm and Term Newborns | The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Number of participants who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Late Preterm and Term Newborns | The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BiliCare TcB Result Compared to TSB Result | Posted | Mean | Standard Deviation | mg/dL | 30 minutes within taking the blood draw for TSB (either before or after the blood draw) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Late Preterm and Term Newborns | The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David L. Schutzman | Albert Einstein Medical Center located in Philadelphia, Pennsylvania, USA | 215-456-6698 | schutzmand@einstein.edu |
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| Hours since birth |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Total Serum Bilirubin (TSB) |
The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method. |
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| 0 |
| 100 |
| 0 |
| 100 |
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