BiliCam Clinical Validation Study

Study Overview
=================
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.

Official Title
-----------------
BiliCam Clinical Validation Study

Conditions
-----------------
Newborn Jaundice

Intervention / Treatment
-----------------
* Device: BiliCam estimated bilirubin (BCB)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Hours
Maximum Age: 191 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Newborns<br>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. | Device: BiliCam estimated bilirubin (BCB)<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCB - TSB Correlation | Pearson correlation coefficient between paired BCB- TSB measurements | Newborns up to 192 hours old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Newborns up to 192 hours old | 
| 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). | Newborns up to 192 hours old |