Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-05 @ 3:42 AM
Study NCT ID:
NCT01763632
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2013-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19601}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-25', 'studyFirstSubmitDate': '2013-01-02', 'studyFirstSubmitQcDate': '2013-01-04', 'lastUpdatePostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth', 'timeFrame': 'Every 12 hr for 168 hr.', 'description': 'During the first postnatal day, transcutaneous bilirubin (TcB) measures were performed at 12-hour time intervals up to the age of 168 hr. TcB data are used to develop an hour-specific TcB nomogram.'}], 'secondaryOutcomes': [{'measure': 'Predictive ability of an hour-specific TcB nomogram', 'timeFrame': 'At the 28 days after birth', 'description': 'Evaluate the rate of rise of bilirubin for different time periods and percentile curves and to assess predictive ability of these percentile curves for hyperbilirubinemia, defined as requirement of phototherapy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hyperbilirubinemia', 'Neonatal', 'Transcutaneous Bilirubin'], 'conditions': ['Hyperbilirubinemia, Neonatal']}, 'descriptionModule': {'briefSummary': 'Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram.\n\nThe investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.', 'detailedDescription': 'Neonatal hyperbilirubinemia is very common; it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe hyperbilirubinemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Term or late-preterm newborn infants from thirteen hospital in China were recruited.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTerm or late-preterm newborn infants with GAs of ≥35 weeks and birth weights of ≥2,000 g were included.\n\nExclusion Criteria:\n\nAll sick newborn infants who were admitted to the intensive care unit.'}, 'identificationModule': {'nctId': 'NCT01763632', 'briefTitle': 'Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China', 'orgStudyIdInfo': {'id': 'NMU-FY2012-318'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcutaneous bilirubinometry', 'type': 'DEVICE', 'description': 'Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510010', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Maternal and Children's Hospital, Guangzhou Medical College", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '530003', 'city': 'Liuchow', 'state': 'Guangxi', 'country': 'China', 'facility': 'Guangxi Maternal and Child Health Hospital', 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}, {'zip': '550003', 'city': 'Guiyang', 'state': 'Guizhou', 'country': 'China', 'facility': 'Guiyang Maternal and Child Health Hospital', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The First Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '410100', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '010020', 'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Inner Mongolia Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Jinlin Provincial Maternal and Child Health Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '300013', 'city': 'Taiyuan', 'state': 'Shaanxi', 'country': 'China', 'facility': 'Shaanxi Provincial Maternal and Child Health Hospital'}, {'zip': '710003', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Shaanxi Provincial Maternal and Child Health Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '830054', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'The First Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'The Third Hospital of Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200011', 'city': 'Shanghai', 'country': 'China', 'facility': 'Gynecology and Obstetrics Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chao Chen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's Hospital of Fudan University"}, {'name': 'Shuping Han, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Maternity and Child Health Care Hospital'}, {'name': 'Zhangbin Yu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Maternity and Child Health Care Hospital'}, {'name': 'Chunming Jiang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Harbin Medical University'}, {'name': 'Yan Gao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinlin Provincial Maternal and Child Health Hospital'}, {'name': 'Xiaomei Tong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}, {'name': 'Meihua Pu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}, {'name': 'Hongyun Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inner Mongolia Maternal and Child Health Care Hospital'}, {'name': 'Kezhan Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanxi Provincial Maternity and Children's Hospital"}, {'name': 'Jin Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University"}, {'name': 'Jimei Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obstetrics & Gynecology Hospital of Fudan University'}, {'name': 'Xiuyong Cheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}, {'name': 'Jie Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Women and Children Hospital'}, {'name': 'Qiufen Wei, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangxi Maternal and Child Health Hospital'}, {'name': 'Zhankui Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanxi Provincial Maternity and Children's Hospital"}, {'name': 'Mingxia Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Xinjiang Medical University'}, {'name': 'Ling Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guiyang Maternity and Child Health Care Hospital'}, {'name': 'Xiaofan Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Maternity and Child Health Care Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, {'name': 'Nanjing Maternity and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'Jinlin Provincial Maternal and Child Health Hospital', 'class': 'UNKNOWN'}, {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': 'Inner Mongolia Maternal and Child Health Care Hospital', 'class': 'OTHER'}, {'name': "Shanxi Provincial Maternity and Children's Hospital", 'class': 'OTHER'}, {'name': 'Obstetrics & Gynecology Hospital of Fudan University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Guangdong Women and Children Hospital', 'class': 'OTHER'}, {'name': 'Guangxi Maternal and Child Health Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': "Sichuan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Guiyang Maternity and Child Health Care Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhangbin Yu', 'investigatorAffiliation': 'Nanjing Medical University'}}}}