BiliCam Clinical Validation Study

Completed

• Conditions: Newborn Jaundice
• Interventions: Device: BiliCam estimated bilirubin (BCB)

• Registration Number: NCT03246503
• Lead Sponsor: BiliCam, LLC

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.

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Study Start: 2017-08-21
• Primary Completion: 2018-02-28
• Study Completion: 2018-04-30
• Disposition First Submitted: 2019-07-08
• Results First Submitted: 2022-03-17
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-08
• Disposition First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Results First Posted: 2022-06-09
• Disposition First Posted: 2022-06-09
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Newborns	BiliCam estimated bilirubin (BCB)	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.

Primary Outcome Measures

Name	Time	Method
BCB - TSB Correlation	Newborns up to 192 hours old	Pearson correlation coefficient between paired BCB- TSB measurements

Secondary Outcome Measures

Name	Time	Method
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).
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).

Trial Locations

Locations (1)

Thomas Jefferson University Hopsital; 🇺🇸 Philadelphia, Pennsylvania, United States