BiliCam Clinical Validation Study
2 other identifiers
interventional
203
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedStudy Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedResults Posted
Study results publicly available
June 9, 2022
CompletedJune 9, 2022
June 1, 2022
6 months
August 8, 2017
March 17, 2022
June 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
BCB - TSB Correlation
Pearson correlation coefficient between paired BCB- TSB measurements
Newborns up to 192 hours old
Secondary Outcomes (2)
Intercept of Regression Line
Newborns up to 192 hours old
Slope of Regression Line
Newborns up to 192 hours old
Study Arms (1)
Newborns
EXPERIMENTALNewborns 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.
Interventions
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 Criteria
You may qualify if:
- Newborn born at ≥ 35 weeks gestation
- Parent speaks and reads English
- Parent provides written informed consent
You may not qualify if:
- previous or ongoing treatment with phototherapy for hyperbilirubinemia
- Medical or other complications that preclude completion of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University Hopsital
Philadelphia, Pennsylvania, 19017, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Taylor
- Organization
- BiliCam, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2017
First Posted
August 11, 2017
Study Start
August 21, 2017
Primary Completion
February 28, 2018
Study Completion
April 30, 2018
Last Updated
June 9, 2022
Results First Posted
June 9, 2022
Record last verified: 2022-06