Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-04 @ 3:09 AM
Study NCT ID:
NCT06645158
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2024-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TCB Self-Monitoring in Healthy Term and Near-Term Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220950}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of TcB Nomogram in Term and Late-preterm Infants from birth to 30 days of age', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'From birth to 7 days of age, newborns should undergo transcutaneous bilirubin monitoring twice daily. From 8 to 14 days of age, jaundice should be monitored once daily, and from 14 to 30 days of age, monitoring should be done at least once every two days.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperbilirubinemia', 'transcutaneous bilirubin', 'neonate'], 'conditions': ['Hyperbilirubinemia, Neonatal']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to monitor the transcutaneous bilirubin (TCB) level in healthy near-term and full-term neonates from birth to 30 days of age across China. The main question it aims to answer is:\n\nDevelopment of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants Compare the changing trend of TCB among different areas in China Compare the changing trend of TCB among different gestational groups in China'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '0 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy neonates from participating hospitals from 26 provinces in China', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGestational age \\>=35wk; did not admitted to hospital for any reason Less than 30 days of age\n\nExclusion Criteria:\n\nAccept phototherapy within 60h of age'}, 'identificationModule': {'nctId': 'NCT06645158', 'briefTitle': 'TCB Self-Monitoring in Healthy Term and Near-Term Neonates', 'organization': {'class': 'NETWORK', 'fullName': 'Neonatal-Infant Brain and Behavior Development Network'}, 'officialTitle': 'Self-Monitoring of Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates: a Multi-center Prospective Study', 'orgStudyIdInfo': {'id': 'Multi-TCB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal neonate', 'description': 'gestational age \\>= 35wk; did not admitted to hospital for any reason; did not need phototherapy within 60h after birth;', 'interventionNames': ['Device: Transcutaneous bilirubin level monitoring']}], 'interventions': [{'name': 'Transcutaneous bilirubin level monitoring', 'type': 'DEVICE', 'description': 'self-monitoring by parents long-term: from birth to 30 days of age', 'armGroupLabels': ['normal neonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Women and Children's Medical Center,', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neonatal-Infant Brain and Behavior Development Network', 'class': 'NETWORK'}, 'collaborators': [{'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}