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Completed

NCT Number: NCT03246503

BiliCam Clinical Validation Study

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.

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Key information

Conditions

Newborn Jaundice Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Jaundice, Neonatal Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 hour–191 hour

Sex eligibility

All sexes

Study type

Interventional

Primary location

Thomas Jefferson University Hopsital

Philadelphia, Pennsylvania, 19017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. BCB - TSB Correlation

    Time frame: Newborns up to 192 hours old

    Pearson correlation coefficient between paired BCB- TSB measurements

Secondary outcomes

  1. Intercept of Regression Line

    Time frame: Newborns up to 192 hours old

    The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).

  2. Slope of Regression Line

    Time frame: Newborns up to 192 hours old

    The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).

Sponsors and collaborators

Lead sponsor

BiliCam, LLC

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2017
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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