Neonatal JaundiceneoSCBNCT06963450
NeoSCB App for Screening Jaundice in Newborns
An observational study of Neonatal Jaundice, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Taking photos of a baby's eye
- How many people
- 405 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2025to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborn babies are all recruited from UCL Hospitals.
Who may be able to join
- Term newborn babies with and without jaundice (postnatal age 0 day to 28 days)
Who cannot join
- Newborn babies who are clinically unwell and require urgent medical attention, and babies who have received phototherapy recently
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
UCL Hospitals
London, NW1 2BU
Judith Meek, MBBS, +442034567890 ext. 78094, judith.meek@nhs.net
About this study
Official title: Clinical Investigation of the Smartphone App neoSCB to Perform Neonatal Jaundice Screening in Newborn Babies
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
- Being tested
- Taking photos of a baby's eye
- Keywords
- screening, newborn babies, mobile app, neonatal jaundice
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking photos of a baby's eyeDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Newborns | Term newborn babies with postnatal age 9 to 28 days Receives: Diagnostic Test: Taking photos of a baby's eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The measurement of scleral-conjunctival bilirubin should take less than 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start23 Sep 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Judith Meek, MBBS, Principal investigator, UCL Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963450
- Sponsor's protocol ID
- 157238
- Other IDs
- NIHR205460
- Acronym
- neoSCB
- Status last verified
- Dec 2025
- First submitted
- 6 May 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data include partial face photos of newborn babies which are personal information and cannot be shared due to privacy concern.
Publications
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.
PubMed 30891343Leung 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.
PubMed 26601015Enweronu-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.
PubMed 35656782Outlaw 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.
PubMed 32119664
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Smartphone App neoSCB to Perform Neonatal Jaundice Screening in Newborn Babies
- ClinicalTrials.gov ID
- NCT06963450
- Acronym / sponsor ID
- neoSCB / 157238
- Conditions
- Neonatal Jaundice
- Keywords
- screening, newborn babies, mobile app, neonatal jaundice
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns | – | Diagnostic Test: Taking photos of a baby's eyeTerm newborn babies with postnatal age 9 to 28 days |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborn babies are all recruited from UCL Hospitals.
Key inclusion criteria (1 listed)
- Term newborn babies with and without jaundice (postnatal age 0 day to 28 days)
Key exclusion criteria (1 listed)
- Newborn babies who are clinically unwell and require urgent medical attention, and babies who have received phototherapy recently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taking photos of a baby's eyeTaking 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. | Diagnostic test | Newborns |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 30891343Leung 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.
- Background: PubMed 26601015Leung 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.
- Background: PubMed 35656782Enweronu-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.
- Background: PubMed 32119664Outlaw 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.
- Website providing background information and methodology of the neoSCB screening appLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The data include partial face photos of newborn babies which are personal information and cannot be shared due to privacy concern.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith Meek, MBBS principal investigator
UCL Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Jaundice, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Terence Leung, PhD (+442076790272, t.leung@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total serum bilirubin (time frame: The measurement of total serum bilirubin should take less than 10 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06963450, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.