CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 203 enrolled
Drug / intervention
BiliCam estimated bilirubin (BCB)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03246503
NCT03246503N/ACompleted
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BiliCam Clinical Validation Study

BiliCam, LLC·interventional·Posted Aug 11, 2017·Updated Jun 9, 2022

In Brief

A clinical study evaluating BiliCam estimated bilirubin (BCB) for Newborn Jaundice. Completed, enrolled 203 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNewborn Jaundice
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 11, 2017
Enrollment StartAug 21, 2017
Primary CompletionFeb 28, 2018
Study CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.9 years ago

Interventions

BiliCam estimated bilirubin (BCB)device

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