About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Term newborn babies with and without jaundice (postnatal age 0 day to 28 days)
Disqualifiers
Newborn babies who are clinically unwell and require urgent medical attention, and babies who have received phototherapy recently
Trial population
Newborn babies are all recruited from UCL Hospitals.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Taking photos of a baby's eye
Diagnostic testTaking photos of a baby's eye and using the color of the sclera to estimate the bilirubin level, which determines if the baby is significantly jaundiced.
Treatment groups
Trial outcomes
Primary outcomes
Total serum bilirubin
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
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.
Sponsors and contacts
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University College, London
Lead sponsor
University College London Hospitals
Collaborator