Transcutaneous Bilirubinometry
Conditions
Keywords
Neonates, Bilicare System
Brief summary
The purpose of this study is to test the performance of a new transcutaneous (measured through skin) bilirubin device (BiliCare™) to measure bilirubin levels. The investigators plan to evaluate the clinical performance of this device as a point of care test. If the investigators can validate the BiliCare™ with bilirubin from your baby's blood they could verify a non-invasive alternative for measuring bilirubin.
Interventions
None listed
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
1. Parental informed consent 2. Male and female newborns with a GA ≥ 35 wks 3. Enrollment at age \> 6 hrs until neonatal discharge 4. Pre-phototherapy
Exclusion criteria
1. Infants requiring respiratory assistance (such as mechanical ventilation) 2. Severe or life-threatening congenital anomalies 3. Hematomas at the point of measurement on both ears 4. Neonates undergone blood transfusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. | 12 to 48 hours |
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) | 113 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 6 |
| Overall Study | Screen Failure | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Late Preterm and Term Newborns |
|---|---|
| Age, Continuous | 38 Weeks STANDARD_DEVIATION 1.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 31 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 36 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 |
Outcome results
Primary
In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.
Time frame: 12 to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BiliCare TcB | In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. | 7.5 mg/dL | Standard Deviation 2.7 |
| BiliCare TcB With Infection Control Tip | In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. | 7.6 mg/dL | Standard Deviation 2.9 |
| JM103 TcB | In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. | 6.1 mg/dL | Standard Deviation 3 |
| Total Serum Bilirubin (TSB) | In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. | 6.4 mg/dL | Standard Deviation 3.2 |