Neonatology Fellow University of Utah School of Medicine Salt Lake City, Utah, United States
Background: Acute bilirubin encephalopathy (ABE) has an incidence of 0.4-2.7 cases per 100,000 births in the United States with outcomes spanning complete recovery to death. Severe hyperbilirubinemia after hospital discharge can lead to undetected and untreated cases of ABE.
The Picterus Jaundice Pro smartphone app, developed by the Norwegian University of Technology and Science, estimates infant bilirubin levels via digital image color analysis. A proprietary color calibration card is placed on the infant’s sternum, and images are taken with flash on and off to correct for lighting, camera, and skin tone variations. The software compares these colors to a database, providing serum bilirubin level estimates. Picterus is available in the European Union but has not been studied in the United States. Objective: To quantify the risk of the Picterus Jaundice Pro App underestimating the serum bilirubin concentration and failing to recommend phototherapy for a neonate with a total serum bilirubin (TSB) at treatment threshold using 2022 AAP Guidelines. Design/Methods: The Intermountain Health institutional review board approved the study protocol (IRB #1052531). Neonates of 35 weeks’ gestation or greater, aged between 24 and 192 hours, and with a serum bilirubin level ordered will qualify for the study. We will obtain a non-invasive Picterus measurement within 1 hour of the TSB. Patient enrollment will begin November 2023. We anticipate collecting 300 paired measurements during 2023-2024 (TSB and Picterus) by March 1, 2024. Of these, 150 paired measurements will be from neonates who have received phototherapy with a light-occlusive patch in place throughout phototherapy. We will estimate the frequency that a Picterus bilirubin value is falsely low when a TSB would have resulted in initiation of phototherapy. Bland-Altman analysis will be used to evaluate the degree of agreement between paired Picterus and serum bilirubin measurements. Based on previous similar studies, we hypothesize that the correlation between serum and Picterus values will be approximately 0.90.
