Clinical Investigation of the Smartphone App neoSCB to Perform Neonatal Jaundice Screening in Newborn Babies

What this Trial Is About

Neonatal jaundice affects about 60% of babies born after 36 weeks of pregnancy within the first two weeks of life. This condition causes a yellow appearance due to bilirubin buildup, which healthcare providers usually detect by looking at the baby's skin and eyes. However, visual checks can be inaccurate, leading to unnecessary hospital blood tests. This study is evaluating the neoSCB smartphone app, which uses photos of a baby's eye to measure jaundice more accurately and economically compared to existing commercial devices. The study is observational and sponsored by University College, London. The study will recruit 405 term newborn babies aged 0 to 28 days, including those with and without jaundice. Researchers will use the neoSCB app to take photos of the baby's sclera and analyze its color to estimate bilirubin levels. Two commercial jaundice screening devices will also be used for comparison. The app will be refined based on feedback from patients and healthcare professionals, and a health economic assessment will evaluate its benefits for the NHS. Participants' bilirubin levels will be measured through blood tests and scleral-conjunctival bilirubin assessments, each taking under 10 and 5 minutes respectively. The study will track these outcomes to validate the app's accuracy. As an observational study, it involves taking photos and measurements without altering treatment. Participation lasts up to 28 days post-birth, with no intervention administered. Researchers aim to improve jaundice screening while monitoring safety and usability throughout the study.

NeoSCB App for Screening Jaundice in Newborns