Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT05089760
Status:
UNKNOWN
Last Update Posted:
2023-08-31
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall mortality', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Incidence of death during the study period'}], 'secondaryOutcomes': [{'measure': 'Sepsis-related mortality (within 7 days of sepsis)', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Incidence of death within 7 days after sepsis'}, {'measure': 'Incidence of multiorgan dysfunction', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Propertion of infants who occur multiorgan dysfunction'}, {'measure': 'Incidence of septic shock', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Propertion of infants who occur septic shock'}, {'measure': 'Incidence of respiratory failure', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Propertion of infants who occur respiratory failure'}, {'measure': 'Incidence of disseminated intravascular coagulation (DIC)', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Propertion of infants who occur DIC'}, {'measure': 'Incidence of renal failure', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Propertion of infants who accur renal failure'}, {'measure': 'Incidence of meningitis', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Propertion of infants who accur meningitis'}, {'measure': 'Incidence of necrotizing enterocolitis', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Propertion of infants who accur necrotizing enterocolitis'}, {'measure': 'Incidence of brain injury', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Propertion of infants who accur brain injury'}, {'measure': 'Length of hospital stay', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Days of hospitalization'}, {'measure': 'Length of antibiotic treatment', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Days of antibiotic treatment'}, {'measure': 'Type and quantity of transfusion', 'timeFrame': 'About 3 months from admission to discharge or death', 'description': 'Which kind and how much (ml) of blood product was used during the study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antimicrobial Resistance', 'Neonatal Sepsis']}, 'descriptionModule': {'briefSummary': 'Neonatal sepsis remains one of the most important cause of mortality and morbidities in China. This study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in Chinese NICUs participating in the Chinese Neonatal Network (CHNN). The microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.', 'detailedDescription': 'All infants with culture-proven sepsis in NICUs of CHNN will be enrolled in the study. Detailed data on microbiology, resistance pattern, neonatal mortality and morbidities will be collected and described. Risk factors for multi-resistant bacteria infections and for sepsis-related mortality will be identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '1 Hour', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All neonates diagnosed with culture-proven sepsis and admitted to CHNN NICUs from 2022.1.1 to 2023.12.31', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31\n* Diagnosed with culture-proven sepsis\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05089760', 'briefTitle': 'Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in Chinese Neonatal Intensive Care Units', 'orgStudyIdInfo': {'id': 'MAROC-ChiNICU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants with bacteria sepsis', 'description': 'Infants diagnosed with culture-proven sepsis', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is a prospective observational cohort study. The purpose of the study was to compare the incidence of mortality, complications, and other outcomes between infants with multi-resistant bacteria sepsis and infants with sepsis caused by non-multi-resistant bacteria, and compare the incidence of complications and other outcomes between infants with sepsis-related death and infants who survive.', 'armGroupLabels': ['Infants with bacteria sepsis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yun Cao, Ph.D. M.D.', 'role': 'CONTACT', 'email': 'yuncao@fudan.edu.cn', 'phone': '+8602164931160'}, {'name': 'Siyuan Jiang, Ph.D. M.D.', 'role': 'CONTACT', 'email': 'jane1350@163.com', 'phone': '+8602164931160'}], 'overallOfficials': [{'name': 'Yun Cao, Ph.D, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University, Shanghai, China"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Neonatal Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}