BiliCam Clinical Validation Study

BiliCam

Status: Completed

Conditions: Newborn Jaundice

Treatments: Device: BiliCam estimated bilirubin (BCB)

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT03246503

52488

R44HD090778 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: Under 191 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 1 patient group

Newborns

Experimental group

Description:

Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are \< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.

Treatment:

Device: BiliCam estimated bilirubin (BCB)