NCT03246503

BiliCam Clinical Validation Study

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: BiliCam, LLC · Industry
• Sex: All
• Age: 0 Hours – 191 Hours
• Healthy volunteers: Accepted

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.

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 clinical decision making. BiliCam is a non-invasive technology used to estimate TSB levels in newborns. With BiliCam, the user obtains digital images of a small portion of a newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized manner. A color calibration card is placed on the baby's sternum to account for varying light conditions. Data on color levels in the photos are used to estimate a bilirubin level. For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a racially and ethnically diverse sample of newborns. Recruitment will continue until 225 newborns have completed the study.

Conditions

• Newborn Jaundice

Interventions

Type	Name	Description
DEVICE	BiliCam estimated bilirubin (BCB)	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

Timeline

• Start date: 2017-08-21
• Primary completion: 2018-02-28
• Completion: 2018-04-30
• First posted: 2017-08-11
• Last updated: 2022-06-09
• Results posted: 2022-06-09

Locations

1 site across 1 country: United States