Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana

Neonatal jaundice is a condition in newborns with elevated levels of the waste product bilirubin, also known as hyperbilirubinemia. It is primarily caused by a combination of the rapid turnover of red blood cells and the immature liver functions in the newborn. Neonatal jaundice affects approximately 60 to 80 % of newborns but is usually self-limiting and harmless. The condition is still potentially dangerous because bilirubin can accumulate in the basal ganglia of the brain, where it can cause permanent brain damage. Such brain damage, better known as kernicterus, can manifest as cerebral palsy, deafness, language difficulty, or in the worst cases, be fatal.

This study will be conducted at a hospital in Botswana, where the study aim to collect data from newborns with a broad range of bilirubin levels and high melanin content.

The investigators hypothesize that the Picterus JP will offer bilirubin level estimates that are highly correlated to bilirubin levels measured in blood samples in a population in Botswana. Following our hypothesis, the short-term goal for this project is to demonstrate that this screening method can be used to identify children with severe neonatal jaundice independent of skin color. Thus, providing a cheaper, patient-friendly, and more readily available means of neonatal jaundice detection.

The study will be a diagnostic accuracy cross-sectional study with quantitative methods of data collection.

The study population will comprise 150 newborns from the Neonatal Unit and the postnatal ward at Princess Marina Hospital, a number determined by a sample size calculation based on standard errors of the 95% limit agreement, as described by Bland and Alman.