NeoSCB App for Screening Jaundice in Newborns

NCT06963450 | Recruiting

• 2 other identifiers: 157238NIHR205460
• Study Type: observational
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Jaundice

Keywords

screening; newborn babies; mobile app; neonatal jaundice

Outcome Measures

Primary Outcomes (2)

• 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.

  The measurement of total serum bilirubin should take less than 10 minutes.

• 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.

  The measurement of scleral-conjunctival bilirubin should take less than 5 minutes.

Study Arms (1)

Newborns

Term newborn babies with postnatal age 9 to 28 days

Diagnostic Test: Taking photos of a baby's eye

Interventions

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.

Newborns

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn babies are all recruited from UCL Hospitals.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator

Study Sites (1)

UCL Hospitals

London, NW1 2BU, United Kingdom

RECRUITING

Related Publications (4)

• Leung TS, Outlaw F, MacDonald LW, Meek J. Jaundice Eye Color Index (JECI): quantifying the yellowness of the sclera in jaundiced neonates with digital photography. Biomed Opt Express. 2019 Feb 14;10(3):1250-1256. doi: 10.1364/BOE.10.001250. eCollection 2019 Mar 1.

  PMID: 30891343 BACKGROUND

• Leung TS, Kapur K, Guilliam A, Okell J, Lim B, MacDonald LW, Meek J. Screening neonatal jaundice based on the sclera color of the eye using digital photography. Biomed Opt Express. 2015 Oct 23;6(11):4529-38. doi: 10.1364/BOE.6.004529. eCollection 2015 Nov 1.

  PMID: 26601015 BACKGROUND

• Enweronu-Laryea C, Leung T, Outlaw F, Brako NO, Insaidoo G, Hagan-Seneadza NA, Ani-Amponsah M, Nixon-Hill M, Meek J. Validating a Sclera-Based Smartphone Application for Screening Jaundiced Newborns in Ghana. Pediatrics. 2022 Jul 1;150(1):e2021053600. doi: 10.1542/peds.2021-053600.

  PMID: 35656782 BACKGROUND

• Outlaw F, Nixon M, Odeyemi O, MacDonald LW, Meek J, Leung TS. Smartphone screening for neonatal jaundice via ambient-subtracted sclera chromaticity. PLoS One. 2020 Mar 2;15(3):e0216970. doi: 10.1371/journal.pone.0216970. eCollection 2020.

  PMID: 32119664 BACKGROUND

Related Links

• Website providing background information and methodology of the neoSCB screening app

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith Meek, MBBS

  UCL Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terence Leung, PhD

CONTACT

+442076790272; t.leung@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 9, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

GB (1)