NeoSCB App for Screening Jaundice in Newborns

NCT ID: NCT06963450

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-23

Study Completion Date

2027-03-31

Brief Summary

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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

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Conditions

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Neonatal Jaundice

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Newborns

Term newborn babies with postnatal age 9 to 28 days

Taking photos of a baby's eye

Intervention Type 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.

Interventions

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Taking photos of a baby's eye

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College London Hospitals

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judith Meek, MBBS

Role: PRINCIPAL_INVESTIGATOR

UCL Hospitals

Locations

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UCL Hospitals

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Terence Leung, PhD

Role: CONTACT

+442076790272

Facility Contacts

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Judith Meek, MBBS

Role: primary

+442034567890 ext. 78094

References

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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.

Reference Type BACKGROUND
PMID: 30891343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26601015 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35656782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32119664 (View on PubMed)

Related Links

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http://www.detect-jaundice.org

Website providing background information and methodology of the neoSCB screening app

Other Identifiers

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NIHR205460

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

157238

Identifier Type: -

Identifier Source: org_study_id

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