We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Conditions
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.
Interventions
DEVICEBiliCare
Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device
Sponsors
Gerium Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Hours to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Late Preterm and Term Newborns The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age) | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Late Preterm and Term Newborns |
|---|---|
| Age, Continuous | 43.5 Hours since birth STANDARD_DEVIATION 19.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiliCare TcB Average | BiliCare TcB Result Compared to TSB Result | 8.46 mg/dL | Standard Deviation 2.68 |
| JM103 TcB | BiliCare TcB Result Compared to TSB Result | 7.93 mg/dL | Standard Deviation 3.48 |
| Total Serum Bilirubin (TSB) | BiliCare TcB Result Compared to TSB Result | 7.83 mg/dL | Standard Deviation 3.27 |