BiliCam Clinical Validation Study
Primary Purpose
Newborn Jaundice
Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
BiliCam estimated bilirubin (BCB)
Sponsored by
About this trial
This is an interventional screening trial for Newborn Jaundice
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
Sites / Locations
- Thomas Jefferson University Hopsital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Newborns
Arm Description
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.
Outcomes
Primary Outcome Measures
BCB - TSB Correlation
Pearson correlation coefficient between paired BCB- TSB measurements
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT03246503
First Posted
August 8, 2017
Last Updated
June 8, 2022
Sponsor
BiliCam, LLC
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03246503
Brief Title
BiliCam Clinical Validation Study
Official Title
BiliCam Clinical Validation Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BiliCam, LLC
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn Jaundice
7. Study Design
Primary Purpose
Screening
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Newborns
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BiliCam estimated bilirubin (BCB)
Intervention Description
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
Primary Outcome Measure Information:
Title
BCB - TSB Correlation
Description
Pearson correlation coefficient between paired BCB- TSB measurements
Time Frame
Newborns up to 192 hours old
Secondary Outcome Measure Information:
Title
Intercept of Regression Line
Description
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
Title
Slope of Regression Line
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
191 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Thomas Jefferson University Hopsital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19017
Country
United States
12. IPD Sharing Statement
Learn more about this trial
BiliCam Clinical Validation Study
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