Validation of a non invasive technology to measure bilirubin in newborns

Project Summary Neonatal jaundice or hyperbilirubinemia is an almost ubiquitous condition in newborn infants In very rare circumstances if an infant with signficant hyperbilirubinemia is undetected kernicterus a devastating and permanent neurologic condition can develop Still rare but much more frequently a neonate with significant jaundice is not identified until the bilirubin level is very high necessitating complicated and expensive care to prevent bilirubin encephalopathy Although the identification of infants with moderate hyperbilirubinemia at levels that are easily treatable is a central focus of neonatal care in the US bilirubin levels typically peak after most neonates are discharged from the newborn nursery There is currently a lack of accurate inexpensive and widely available methodologies to screen discharged infants for jaundice leaving a notable void in the overall system of care designed to prevent severe hyperbilirubinemia Our group has developed a non invasive technology called BiliCam to measure bilirubin in newborn infants The technology is based on the analysis of digital images of newborn skin that are obtained with a smartphone app that we have developed Based on this analysis a bilirubin estimate is calculated and displayed on the smartphone A study to collect data do develop and finalize the algorithm converting data from the images into an estimate bilirubin level is currently in progress To date a racially and ethnically diverse sample of over newborn infants from sites across the United States have been enrolled in this study The results are very promising BiliCam provides estimates of bilirubin that are similar in accuracy to those achieved with a transcutaneous bilirubinometer the predicate device Data collection for the study will conclude in late and the algorithm will be finalized In order to commercialize the technology the developers have formed a private company BiliCam LLC In a presubmission meeting with the Food and Drug Administration FDA the studies needed to be completed to support a k submission for initial clearance for Bilicam were described The overall goal of the proposed project is to conduct these studies needed for obtaining FDA clearance First a clinical validation study will be conducted using BiliCam to estimate bilirubin levels in a diverse sample of andgt newborns from three sites The estimated bilirubin levels will be compared to the total serum bilirubin TSB level the gold standard for clinical decision making in the newborns Second the reproducibility of BiliCam results will be assessed using different smartphones with the app installed to obtain sets of images from phantoms representing various bilirubin levels over readings will be obtained Finally the usability of the BiliCam app will be assessed in healthcare professionals who are the intended users for the initial clearances for the technology A two year study period is planned !Project narrative BiliCam is a smartphone app based system that can be used to measure bilirubin in newborns that could be used to provide better and less expensive healthcare In order for BiliCam to be used in clinical settings clearance is needed from the Food and Drug Administration FDA The goal of the proposed project is to conduct the studies need to support an application for FDA clearance for the technology