NeoSCB App for Screening Jaundice in Newborns
- Conditions
- Neonatal Jaundice
- Registration Number
- NCT06963450
- Lead Sponsor
- University College, London
- Brief Summary
About 60% of babies born after 36 weeks of pregnancy have jaundice during the first two weeks of life. Due to the accumulation of bilirubin in the bloodstream, jaundiced babies appear yellow, which allows healthcare professionals to visually identify significantly jaundiced babies. They will be referred for a blood test to determine if the bilirubin level is so high that treatment such as phototherapy, or more intensive help is required. Left untreated or treatment delayed, jaundice can potentially result in serious brain damage and even death (rare). However, visual inspection of jaundiced babies is inaccurate, often need to unnecessary referrals to hospital blood tests. We have developed the "neoSCB" smartphone app, which accurately detects significant jaundice by taking photographs of the baby's sclera (white part of an eye) and analysing its yellowness using a diagnostic algorithm. The neoSCB app has previously been validated in Ghana involving over 700 newborn babies. In this new study, we will recruit 405 newborn babies with a range of jaundice levels to validate an optimised diagnostic algorithm following our latest research. Two existing commercial screening devices will also be used to investigate whether the app delivers a similar accuracy, at a fraction of the cost. We will enhance the usability of the app and add new features following feedback from patients and healthcare professionals. A health economic study will be conducted to evaluate the economic benefits to the NHS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 405
- Term newborn babies with and without jaundice (postnatal age 0 day to 28 days)
- Newborn babies who are clinically unwell and require urgent medical attention, and babies who have received phototherapy recently
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total serum bilirubin The measurement of total serum bilirubin should take less than 10 minutes. Total serum bilirubin is measured by taking a blood sample from the newborn baby. It is a standard way to assess how jaundiced the baby is and if a treatment is necessary.
Scleral-conjunctival bilirubin The measurement of scleral-conjunctival bilirubin should take less than 5 minutes. Scleral-conjunctival bilirubin is estimated from digital photos of the baby's eye, based on the color of the sclera. It is a non-invasive way to estimate bilirubin, allowing the assessment of how jaundiced a baby is and whether a confirmatory blood test is required.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCL Hospitals
🇬🇧London, United Kingdom