BiliCam Clinical Validation Study

BiliCam, LLC203 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

203

Conditions

Newborn Jaundice

Interventions

BiliCam estimated bilirubin (BCB)DEVICE

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

Eligibility

Sex: ALLMin age: 0 HoursMax age: 191 HoursHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University Hopsital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

BCB - TSB Correlation

Pearson correlation coefficient between paired BCB- TSB measurements

Time frame: Newborns up to 192 hours old

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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