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
Two measurements with the BiliCare device
Sponsors
Gerium Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Signed parental informed consent 2. Gestational Age \>=24 weeks
Exclusion criteria
1. Less than 24 weeks of pregnancy at delivery 2. Bruising at the point of measurement on both ears 3. Birthmarks at the point of measurement on both ears 4. Hematomas at the point of measurement on both ears 5. Excessive Hairiness at the point of measurement on both ears 6. Neonate is during Phototherapy or has been exposed to phototherapy treatment during the last six hours
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
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preterm, Late Preterm and Term Newborns The study population will consist of preterm, late preterm and term newborns (infants \>=24 weeks gestational age) | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 18 |
Baseline characteristics
| Characteristic | Preterm, Late Preterm and Term Newborns |
|---|---|
| Age, Customized 24<=Gestational Age [weeks]<35 | 33.2 Weeks STANDARD_DEVIATION 2 |
| Age, Customized 35<=Gestational Age [weeks] | 38.9 Weeks STANDARD_DEVIATION 1.8 |
| Race/Ethnicity, Customized African or Bedouin (Dark Skin tone) | 0 participants |
| Race/Ethnicity, Customized Caucasian (White or Tan skin tone)) | 93 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 93 |
| serious Total, serious adverse events | 0 / 93 |
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 | 8.0 mg/dL | Standard Deviation 4.4 |
| Total Serum Bilirubin (TSB) | BiliCare TcB Result Compared to TSB Result | 7.3 mg/dL | Standard Deviation 3.9 |