BiliCam Clinical Validation Study

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.

Study Overview

• Status: Completed
• Conditions: Newborn Jaundice
• Intervention / Treatment: Device: BiliCam estimated bilirubin (BCB)

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 Type: Interventional
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19017
      • Thomas Jefferson University Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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

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

Collaborators and Investigators

• Sponsor: BiliCam, LLC
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Bilirubin
• Other Study ID Numbers: 52488; R44HD090778 (U.S. NIH Grant/Contract)