N/A
Completed N=203
BiliCam Clinical Validation Study
Newborn Jaundice
Source: ClinicalTrials.gov NCT03246503 ↗
Enrolled (actual)
203
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: BCB - TSB Correlation — 0.82 correlation coefficient — p=<.001
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.
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 |
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. Informational only — not medical advice.