Clinical study
UK
Join us for our upcoming clinical study in the UK. Building on our previous study in Ghana, this study at UCLH aims to validate neoSCB for the UK, potentially saving the NHS millions while ensuring timely treatment for newborns.
Study Overview
Our new clinical study at University College London Hospitals (UCLH) aims to validate the neoSCB app’s effectiveness in detecting neonatal jaundice in a diverse UK population, following the success in Ghana. This two-year project will culminate in a validated app, ready for regulatory certification and commercialisation.
Methodology
- Participants: 405 jaundiced newborns referred by home-visiting midwives.
- Procedure: Use the enhanced neoSCB app to capture scleral images, comparing results with gold standard blood tests.
- Data Collection: Focuses on the app’s sensitivity, specificity and usability in a clinical setting.
Objectives
Validate Accuracy
Assess the app’s accuracy compared to standard clinical methods.
Evaluate Usability
Ensure user-friendliness and regulatory compliance.
Regulatory Approval
Prepare for UKCA or CE marks and commercialisation.
Health Economic Analysis
Estimate potential NHS savings from reduced unnecessary hospital referrals.
Timelines
The project will take two years to complete. By the end, a validated neoSCB app, supported by technical documentation, will be ready for regulatory certification and commercialisation.
Anticipated Impact and Dissemination
The vision is to equip every midwife in the UK with our affordable screening app, potentially saving the NHS over £4.3M annually from unnecessary blood test referrals, while ensuring timely treatment for severely jaundiced newborns. Study results will be shared with healthcare professionals and parents through conferences, journals and a short animation introducing the neoSCB app.
