Status:
COMPLETED
BiliCam Clinical Validation Study
Lead Sponsor:
BiliCam, LLC
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Newborn Jaundice
Eligibility:
All Genders
Up to 191 years
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 tota...
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 clinica...
Eligibility Criteria
Inclusion
- Newborn born at ≥ 35 weeks gestation
- Parent speaks and reads English
- Parent provides written informed consent
Exclusion
- previous or ongoing treatment with phototherapy for hyperbilirubinemia
- Medical or other complications that preclude completion of the study
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT03246503
Start Date
August 21 2017
End Date
April 30 2018
Last Update
June 9 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Thomas Jefferson University Hopsital
Philadelphia, Pennsylvania, United States, 19017