Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 11:08 AM
Study NCT ID:
NCT06963450
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NeoSCB App for Screening Jaundice in Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007567', 'term': 'Jaundice, Neonatal'}], 'ancestors': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 405}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total serum bilirubin', 'timeFrame': 'The measurement of total serum bilirubin should take less than 10 minutes.', 'description': '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.'}, {'measure': 'Scleral-conjunctival bilirubin', 'timeFrame': 'The measurement of scleral-conjunctival bilirubin should take less than 5 minutes.', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening', 'newborn babies', 'mobile app', 'neonatal jaundice'], 'conditions': ['Neonatal Jaundice']}, 'referencesModule': {'references': [{'pmid': '30891343', 'type': 'BACKGROUND', 'citation': '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': '26601015', 'type': 'BACKGROUND', 'citation': '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': '35656782', 'type': 'BACKGROUND', 'citation': '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': '32119664', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.detect-jaundice.org', 'label': 'Website providing background information and methodology of the neoSCB screening app'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborn babies are all recruited from UCL Hospitals.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term newborn babies with and without jaundice (postnatal age 0 day to 28 days)\n\nExclusion Criteria:\n\n* Newborn babies who are clinically unwell and require urgent medical attention, and babies who have received phototherapy recently'}, 'identificationModule': {'nctId': 'NCT06963450', 'acronym': 'neoSCB', 'briefTitle': 'NeoSCB App for Screening Jaundice in Newborns', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Clinical Investigation of the Smartphone App neoSCB to Perform Neonatal Jaundice Screening in Newborn Babies', 'orgStudyIdInfo': {'id': '157238'}, 'secondaryIdInfos': [{'id': 'NIHR205460', 'type': 'OTHER_GRANT', 'domain': 'National Institute for Health and Care Research'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newborns', 'description': 'Term newborn babies with postnatal age 9 to 28 days', 'interventionNames': ["Diagnostic Test: Taking photos of a baby's eye"]}], 'interventions': [{'name': "Taking photos of a baby's eye", 'type': 'DIAGNOSTIC_TEST', 'description': "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.", 'armGroupLabels': ['Newborns']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW1 2BU', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Judith Meek, MBBS', 'role': 'CONTACT', 'email': 'judith.meek@nhs.net', 'phone': '+442034567890', 'phoneExt': '78094'}], 'facility': 'UCL Hospitals', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Terence Leung, PhD', 'role': 'CONTACT', 'email': 't.leung@ucl.ac.uk', 'phone': '+442076790272'}], 'overallOfficials': [{'name': 'Judith Meek, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data include partial face photos of newborn babies which are personal information and cannot be shared due to privacy concern.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College London Hospitals', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}