Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT05623566
Status:
TERMINATED
Last Update Posted:
2024-04-04
First Post:
2022-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, 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': 'ACTUAL', 'count': 284}}, 'statusModule': {'whyStopped': 'After data quality check, inclusion criteria were not satisfied and data quality was poor. We concluded that results are not reliable', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.', 'timeFrame': '5-10 minutes', 'description': 'Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns.'}], 'secondaryOutcomes': [{'measure': 'Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn', 'timeFrame': '1-2 minutes', 'description': 'To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice'}, {'measure': 'correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns', 'timeFrame': '5-10 minutes', 'description': 'To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice'}, {'measure': 'Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns', 'timeFrame': '5-10 minutes', 'description': 'To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Jaundice, Neonatal']}, 'descriptionModule': {'briefSummary': 'A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.', 'detailedDescription': "A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya.\n\nThis cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. The Picterus Calibration Card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP was used to collect digital images."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '1 Hour', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born with gestational age \\>31\n* Birth weight ≥ 1500g\n* Age 0 - ≤14 days\n* Consent obtained from the parents\n\nExclusion Criteria:\n\n* Infants born with congenital abnormalities;\n* Infants respiratory support;\n* Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure;\n* Infants who have received phototherapy in the last 24 hours.'}, 'identificationModule': {'nctId': 'NCT05623566', 'briefTitle': 'Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Picterus AS'}, 'officialTitle': 'Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia', 'orgStudyIdInfo': {'id': '2018/1608Indonesia'}}, '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 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 for all skin colors.', 'interventionNames': ['Device: Picterus Jaundice Pro']}], 'interventions': [{'name': 'Picterus Jaundice Pro', 'type': 'DEVICE', 'otherNames': ['Picterus JP'], 'description': 'In this study we aim to collect data of newborns with wider range of bilirubin levels 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 for all skin colors.', 'armGroupLabels': ['Enable high qualitative estimation of bilirubin levels in the blood of new-borns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60115', 'city': 'Surabaya', 'state': 'East Java', 'country': 'Indonesia', 'facility': 'Airlangga University hospital', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}, {'zip': '60134', 'city': 'Surabaya', 'state': 'East Java', 'country': 'Indonesia', 'facility': 'RSIA Kendangsari MERR', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}, {'zip': '60286', 'city': 'Surabaya', 'state': 'East Java', 'country': 'Indonesia', 'facility': 'Dr. Soetomo General Hospital', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Picterus AS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'RSIA Kendangsaru Surabaya', 'class': 'UNKNOWN'}, {'name': 'Universitas Airlangga', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}