Newborn Jaundice
Conditions
Brief summary
The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will be compared to total serum bilirubin levels in up to 225 newborns.
Detailed description
Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB levels in newborns. With BiliCam, the user obtains digital images of a small portion of a newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized manner. A color calibration card is placed on the baby's sternum to account for varying light conditions. Data on color levels in the photos are used to estimate a bilirubin level. For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a racially and ethnically diverse sample of newborns. Recruitment will continue until 225 newborns have completed the study.
Interventions
DEVICEBiliCam estimated bilirubin (BCB)
Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
BiliCam, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Hours to 191 Hours
Healthy volunteers
Yes
Inclusion criteria
* Newborn born at ≥ 35 weeks gestation * Parent speaks and reads English * Parent provides written informed consent
Exclusion criteria
* previous or ongoing treatment with phototherapy for hyperbilirubinemia * Medical or other complications that preclude completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCB - TSB Correlation | Newborns up to 192 hours old | Pearson correlation coefficient between paired BCB- TSB measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intercept of Regression Line | Newborns up to 192 hours old | The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis). |
| Slope of Regression Line | Newborns up to 192 hours old | The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Newborns Newborns will be enrolled in the study in 2 different ways. At Staged Enrollment sites, newborns will be enrolled when they are \< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At Simultaneous Enrollment sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.
BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care | 203 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 23 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Received phtototherapy prior to study visit=4, blood specimen not obtained =1 | 5 |
| Overall Study | Withdrawal by Subject | 20 |
Baseline characteristics
| Characteristic | Newborns |
|---|---|
| Age, Continuous | 95.7 hours STANDARD_DEVIATION 27.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants |
| Race (NIH/OMB) Black or African American | 61 Participants |
| Race (NIH/OMB) More than one race | 39 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 80 Participants |
| Region of Enrollment United States | 203 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 151 |
| other Total, other adverse events | 0 / 151 |
| serious Total, serious adverse events | 0 / 151 |
Outcome results
Primary
BCB - TSB Correlation
Pearson correlation coefficient between paired BCB- TSB measurements
Time frame: Newborns up to 192 hours old
Population: Participants who completed study visit and had valid paired TSB-BCB results. There were 3 participants in whom blood was obtained for TSB levels, but no valid measurement was available (1 grossly hemolyzed sample, 1 specimen lost, and 1 specimen not obtained within 2 hours of the BCB level). There were 3 participants in whom a BCB level could not be obtained by the study device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Newborns | BCB - TSB Correlation | 0.82 correlation coefficient |
Comparison: Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.p-value: <0.00195% CI: [0.77, 0.87]Pearson correlation coefficient
Secondary
Intercept of Regression Line
The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).
Time frame: Newborns up to 192 hours old
Population: Participants with valid paired BCB and TSB values
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Newborns | Intercept of Regression Line | 4.13 mg/dL |
p-value: <0.00195% CI: [3.35, 4.91]Regression, Linear
Secondary
Slope of Regression Line
The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).
Time frame: Newborns up to 192 hours old
Population: Participants with valid paired BCB and TSB values
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Newborns | Slope of Regression Line | 0.68 slope |
p-value: <0.00195% CI: [0.6, 0.76]Regression, Linear