The neoSCB smartphone app - an equitable solution for jaundice screening in newborn babies

Background Neonatal jaundice is a common condition affecting approximately 60% of all newborn babies. During a home visit, a newborn baby will be checked by a community midwife who will look for signs of jaundice, e.g., yellow skin discolouration. Jaundice appearance, however, is more difficult to spot in babies with dark skin tones, which can delay treatment referrals for those with significant jaundice (bilirubin levels>250 micromol/litre). We have developed the neoSCB app to screen newborn babies for significant jaundice using a smartphone camera (TRL5). It estimates the bilirubin level based on the yellowness of the sclera colour of the eye instead of the skin colour, so is applicable to babies of all skin tones. In a previous study in Ghana involving 336 newborn babies, we have shown that the app has sensitivity of 100% and specificity of 74% in screening babies with significant jaundice. Aims and objectives Our ultimate aim is to equip community midwives with the neoSCB app during home visits, providing a low-cost, accessible technique to make an accurate assessment of neonatal jaundice in newborn babies of all skin tones. In this project, the 1st objective is to carry out a usability study for the neoSCB app based on MHRA guidelines. This is a crucial step in the regulatory approval process to gain UKCA certification, a prerequisite for the neoSCB app to be legally adopted in the NHS. The 2nd objective is to upskill the research team with entrepreneurship training provided by this scheme and develop a viable business plan and map out the translation pathway for the neoSCB app. Methods Based on the MHRA guidelines on human factors and usability engineering, we will recruit 5 midwives to participate in a formative testing of the neoSCB app and training documents, and their feedback will be used to improve the app and training documents. We will then recruit 20 community midwives (intended users) in a summative study to test the neoSCB app on newborn babies during home visits (intended environment). A researcher will join the visits and evaluate each task performed by the community midwife. The summative assessment will focus on the completion of tasks and collect personal views. Parents’ views on the neoSCB app will also be recorded. The results will be written up in a usability report, which forms part of the technical file for regulatory approval submission. Timelines for delivery The usability study will complete in 9 months, including ethics and MHRA applications (will start when the award is confirmed). The entrepreneurship training will also be completed within the same time frame (+1 session in Sep 2026). Knowledge mobilisation, dissemination and impact The multi-disciplinary team consists of investigators with skillsets complimenting one another, including two clinicians, a bioengineer and a regulatory consultant. They are all investigators of an on-going NIHR funded hospital-based project, which will overlap in time with the proposed project, allowing us to tap into the expertise and network of the existing research team, consisting of a research midwife, a research nurse and a software engineer, who can assist the recruitment of community midwives and revise the neoSCB app in response to new feedback. Research Inclusion During the recruitment of participating community midwives and newborn babies, we will ensure a diverse range of ethnicities is included in the study.