Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-25 @ 8:19 PM
Study NCT ID:
NCT03227302
Status:
UNKNOWN
Last Update Posted:
2020-01-09
First Post:
2017-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Associations of the Grades of Doctor and Neonatal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neonatal asphyxia', 'timeFrame': 'within 28 days', 'description': 'neonatal asphyxia was defined according to manual of neonatal care'}, {'measure': 'death', 'timeFrame': 'within 28 days', 'description': 'neonatal death'}], 'secondaryOutcomes': [{'measure': 'Bayley Scales of Infant Development', 'timeFrame': 'at 2 months and 2 years old', 'description': 'to assess the development using Bayley Scales of Infant Development'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Standardized Training System for Residents', 'Neonatal Outcomes']}, 'descriptionModule': {'briefSummary': 'In China, the standardized training system for residents was built last year, and the associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.', 'detailedDescription': 'In China, the grades of doctors and accoucheurs are divided into four levels, and different levels may induce differences of neonatal asphyxia and death. The standardized training system for residents was built last year,the associations of the grades of doctors and accoucheurs and neonatal asphyxia,neonatal death before and after the training systems need to be assess.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '100 Days', 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All neonates with gestational age are from 26 weeks to 42 weeks', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age (GA) is from 26 to 42 weeks\n\nExclusion Criteria:\n\n* major congenital malformations or complex congenital heart disease'}, 'identificationModule': {'nctId': 'NCT03227302', 'briefTitle': 'Associations of the Grades of Doctor and Neonatal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Associations of the Grades of Doctor and Neonatal Outcomes: An Observational Prospective Study', 'orgStudyIdInfo': {'id': 'grades of doctor and neonaltal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'attending obstetrician', 'description': 'the low grade doctor who can do caesarean operation with no pregnant complications.', 'interventionNames': ['Procedure: attending obstetrician']}, {'label': 'associate chief obstetrician', 'description': 'The middle grade doctor who can do caesarean operation with no or mild or middle pregnant complications.', 'interventionNames': ['Procedure: associate obstetrician']}, {'label': 'chief obstetrician', 'description': 'the high doctor who can do all caesarean operation without limitations', 'interventionNames': ['Procedure: chief obstetrician']}], 'interventions': [{'name': 'attending obstetrician', 'type': 'PROCEDURE', 'description': 'Attending obstetrician can do the caesarean operation without pregnant complications.', 'armGroupLabels': ['attending obstetrician']}, {'name': 'associate obstetrician', 'type': 'PROCEDURE', 'description': 'Associate chief Obstetrician can do the caesarean operation without or mild or middle pregnant complications.', 'armGroupLabels': ['associate chief obstetrician']}, {'name': 'chief obstetrician', 'type': 'PROCEDURE', 'description': 'Chief obstetrician can do all caesarean operation without limitations.', 'armGroupLabels': ['chief obstetrician']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Ma, physician', 'role': 'CONTACT', 'email': 'zoe330@163.com', 'phone': '18680887330'}], 'facility': 'Department of Pediatrics, Daping Hospital, Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Ma Juan, MD', 'role': 'CONTACT', 'email': '476679422@qq.com', 'phone': '13883559467'}], 'overallOfficials': [{'name': 'Shi Yuan, PhD,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ma Juan', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}