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NCT Number: NCT06963450

NeoSCB App for Screening Jaundice in Newborns

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.

Recruiting

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Key information

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

UCL Hospitals

London, NW1 2BU, United Kingdom

Location status: Recruiting

Location contact

Judith Meek, MBBS

CONTACT

[email protected]

+442034567890 ext. 78094

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Term newborn babies with and without jaundice (postnatal age 0 day to 28 days)

Exclusion criteria

  • Newborn babies who are clinically unwell and require urgent medical attention, and babies who have received phototherapy recently

Treatment and study plan

Taking photos of a baby's eye

Diagnostic Test

Taking 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.

Primary outcomes

  1. Total serum bilirubin

    Time frame: 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.

  2. Scleral-conjunctival bilirubin

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Terence Leung, PhD

CONTACT

[email protected]

+442076790272

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • University College London Hospitals

Registry information

Official study title

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

Acronym: neoSCB

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 9, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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