Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-04-11 @ 11:22 AM
Study NCT ID:
NCT05630495
Status:
UNKNOWN
Last Update Posted:
2023-07-14
First Post:
2022-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns', 'timeFrame': '6 months', 'description': 'Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.'}], 'secondaryOutcomes': [{'measure': 'Correlation with TcB', 'timeFrame': '5-10 minutes', 'description': 'Correlate the estimates of bilirubin levels obtained by Picterus with TcB'}, {'measure': 'Correlation with Tsb and TcB', 'timeFrame': '1-2 hours', 'description': 'Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB'}, {'measure': 'Picterus JP accuracy in Indonesian newborn', 'timeFrame': '6 months', 'description': 'Determine the accuracy of Picterus in Indonesian newborns'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Jaundice, Neonatal']}, 'descriptionModule': {'briefSummary': "The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:\n\n* Demonstrate that Picterus system performs accurately in Indonesian newborns\n* Ensure that Picterus is in line with users' needs in Indonesia", 'detailedDescription': "The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:\n\n* Demonstrate that Picterus system performs accurately in Indonesian newborns\n* Ensure that Picterus is in line with users' needs in Indonesia"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Infants born with gestational age ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 days\n\nExclusion Criteria:\n\n\\- Infants transferred to the pediatric ward for advanced treatment. Infants with a skin rash or other disease that affects the skin where measurements are performed.\n\nInfants that receive or have received phototherapy in the last 24 hours. Infants with an inborn disease'}, 'identificationModule': {'nctId': 'NCT05630495', 'briefTitle': 'Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Picterus AS'}, 'officialTitle': 'Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia', 'orgStudyIdInfo': {'id': '2018/1608Indonesia2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enable high qualitative estimation of bilirubin levels in the blood of new-borns', 'description': 'In this study we aim to collect data of newborns with wider range of bilirubin levels and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns of South-East Asian ethnicity and skin type.', 'interventionNames': ['Device: Picterus Jaundice Pro']}], 'interventions': [{'name': 'Picterus Jaundice Pro', 'type': 'DEVICE', 'otherNames': ['Picterus JP'], 'description': 'Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.', 'armGroupLabels': ['Enable high qualitative estimation of bilirubin levels in the blood of new-borns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60115', 'city': 'Surabaya', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Mahendra Tri Arif Sampurna, dr., Sp.A(K), PhD', 'role': 'CONTACT', 'email': 'mahendra.tri@fk.unair.ac.id'}, {'name': 'Mahendra Tri Arif Sampurna, dr., Sp.A(K), PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitas Airlangga Teaching Hospital', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}, {'zip': '60134', 'city': 'Surabaya', 'status': 'COMPLETED', 'country': 'Indonesia', 'facility': 'RSIA Kendangsari MERR hospital', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}], 'centralContacts': [{'name': 'Mahendra TA Sampurna, Dr, SP.A', 'role': 'CONTACT', 'email': 'mahendra.tri@fk.unair.ac.id', 'phone': '+62 031-5916290'}], 'overallOfficials': [{'name': 'Anders Aune, MD,MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Picterus AS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Picterus AS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Airlangga University', 'class': 'UNKNOWN'}, {'name': 'RSIA Kendangsaru MERR Surabaya', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}