N/A
N=203
BiliCam Clinical Validation Study
Newborn Jaundice
Bottom Line
View on ClinicalTrials.gov: NCT03246503 ↗Enrolled (actual)
203
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: BCB - TSB Correlation — 0.82 correlation coefficient — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BiliCam estimated bilirubin (BCB) (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- BiliCam, LLC
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BCB - TSB Correlation |
0.82 | <.001 sig |
| SECONDARY Intercept of Regression Line |
4.13 | <.001 sig |
| SECONDARY Slope of Regression Line |
0.68 | <.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03246503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.