[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655666":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":32,"studyPopulation":33,"armGroups":34,"interventions":28,"overallOfficials":44,"centralContacts":54,"locations":61,"responsibleParty":94,"collaborators":96,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":28,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":28,"studyType":116,"phases":28,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":128,"whyStopped":28,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Zhejiang Provincial Center for Disease Control and Prevention","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Respiratory infection-related healthcare visit or hospitalization events","Multiplex respiratory pathogen PCR assay","From enrollment through 48 months",{"measure":14,"description":15,"timeFrame":16},"Transcriptional profiles of peripheral blood mononuclear cells (PBMCs)","Single-cell RNA sequencing and analysis will be performed on PBMCs collected at the annual study visits.","Baseline, 12, 24, 36 and 48 months",[18,22,25],{"measure":19,"description":20,"timeFrame":21},"Vaccine-induced antibody response","Antibody levels against hepatitis B, pertussis, and varicella vaccine antigens will be measured in samples collected at the annual study visits.","Baseline and 12, 24, 36, and 48 months",{"measure":23,"description":24,"timeFrame":21},"Antibody levels against respiratory pathogens","Respiratory syncytial virus (RSV) neutralizing antibodies, Humanmetapneumovirus (HMPV) neutralizing antibodies, Parainfluenza virus (PIV) neutralizing antibodies, and Mycoplasma pneumoniae IgG will be measured in samples collected at the annual study visits.",{"measure":26,"description":27,"timeFrame":21},"Gut Microbiome Diversity","Metagenomic sequencing will be performed on stool samples collected at the annual study visits.",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":31,"maskingInfo":28},"COHORT","PROSPECTIVE","This prospective observational cohort study combines scheduled longitudinal assessments, active surveillance of respiratory infections, healthcare data linkage, and biospecimen-based laboratory analyses to characterize biomarkers of anti-infective immunity in children and assess their risk of infection.\n\nQuestionnaire data and biological samples will be collected at baseline and annual visits. Respiratory infection events will be monitored through regular contact with participants' families, voluntary symptom reporting, sentinel hospital surveillance, and available healthcare records. Remote follow-up will generally occur every 8 to 12 weeks and may increase to every 4 weeks during periods of increased respiratory pathogen activity.\n\nEligible respiratory infection events will trigger acute-phase sampling, preferably within 3 days after illness onset or at the initial clinical visit, and recovery-phase sampling at 21 ± 4 days after onset. All eligible respiratory infection-related hospitalizations will trigger sampling. Outpatient or emergency department events may trigger sampling no more than twice per participant per year, with an interval of at least 6 weeks between events.\n\nLaboratory assessments may include vaccine- and pathogen-specific antibodies, respiratory pathogen detection, cytokines, gut microbiome analysis, genomic analysis, and selected single-cell analyses.","The study population will consist of approximately 1,200 children from birth through 7 years of age who reside in the participating study areas in Zhejiang Province, China, and are available for long-term follow-up. Participants will be recruited from community settings and participating healthcare institutions into three predefined cohorts: approximately 600 children from the general community without known serious underlying disease, 400 children with a history of infection-related hospitalization or recurrent respiratory infections, and 200 children with physician-confirmed asthma. Recruitment targets will be stratified by age, with efforts to maintain reasonable balance by sex and urban or rural residence.",[35,38,41],{"label":36,"type":28,"description":37,"interventionNames":28},"General Community Cohort","Approximately 600 children aged 0-7 years recruited from the general community who have no known serious underlying disease at enrollment. Participants will undergo questionnaires, longitudinal health surveillance, medical and vaccination record collection, and scheduled biospecimen collection. No intervention will be assigned.",{"label":39,"type":28,"description":40,"interventionNames":28},"Infection Observation Cohort","Approximately 400 children aged 0-7 years who either had an infection-related hospitalization before 3 years of age with documented information on the pathogen, infection site, or clinical diagnosis, or had at least three healthcare visits for respiratory infections during the 12 months before enrollment. Participants will undergo the same observational follow-up and biospecimen collection procedures. No intervention will be assigned.",{"label":42,"type":28,"description":43,"interventionNames":28},"Childhood Asthma Cohort","Approximately 200 children aged 1 through 7 years with physician-confirmed asthma or highly suspected asthma according to the protocol-defined age-specific clinical criteria. No intervention will be assigned.",[45,49,52],{"name":46,"affiliation":47,"role":48},"Jun Zhang, Master","Xiamen University","STUDY_CHAIR",{"name":50,"affiliation":5,"role":51},"Hanqing He, PhD","PRINCIPAL_INVESTIGATOR",{"name":53,"affiliation":47,"role":51},"Tianying Zhang, PhD",[55,59],{"name":50,"role":56,"phone":57,"phoneExt":28,"email":58},"CONTACT","+86-571-87115170","hanqinghe@cdc.zj.cn",{"name":53,"role":56,"phone":28,"phoneExt":28,"email":60},"zhangtianying@xmu.edu.cn",[62,80],{"facility":63,"status":28,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Dongyang Center for Disease Control and Prevention","Dongyang","Zhejiang","322100","China","CN",{"type":70,"coordinates":71},"Point",[72,73],120.22528,29.26778,{"lat":73,"lon":72},[76],{"name":77,"role":56,"phone":78,"phoneExt":28,"email":79},"Bin Guo, Master","+86-579-86655600","534063265@qq.com",{"facility":81,"status":28,"city":82,"state":65,"zip":83,"country":67,"countryCode":68,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Yiwu Center for Disease Control and Prevention","Yiwu","322000",{"type":70,"coordinates":85},[86,87],120.07676,29.31506,{"lat":87,"lon":86},[90],{"name":91,"role":56,"phone":92,"phoneExt":28,"email":93},"Jun Jiang, Master","+86-579-89938190","271477702@qq.com",{"type":95,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[97,99],{"name":47,"class":98},"OTHER",{"name":100,"class":101},"Xiang An Biomedicine Laboratory","UNKNOWN","100655666","childhood-infection-and-immunity-longitudinal-cohort-100655666",false,"NCT07815925","Childhood Infection and Immunity Longitudinal Cohort","Childhood Infection and Immunity Longitudinal Cohort (KIDTRACE)","Inclusion Criteria:\n\n* Children from birth through 7 years of age (younger than 8 years at enrollment).\n* The participant's parent or legal guardian is able to understand the study, voluntarily agrees to participation, and provides written informed consent.\n* The participant resides in the study area and is expected to be available for long-term follow-up.\n* For the General Community Cohort: no known serious underlying disease before enrollment.\n* For the Infection Observation Cohort: either a history of hospitalization for an infectious disease before 3 years of age, with documented information on the pathogen, infection site, or clinical diagnosis; or at least three healthcare visits for respiratory infections during the 12 months before enrollment.\n* For the Childhood Asthma Cohort: physician-confirmed asthma or highly suspected asthma according to the protocol-defined age-specific criteria. Children younger than 1 year will not be included in this cohort.\n\nExclusion Criteria:\n\n* An acute illness within 14 days before enrollment, including respiratory, gastrointestinal, dermatologic, or urinary symptoms or conditions specified in the protocol.\n* Known primary immunodeficiency, malignant tumor, serious congenital disorder, or another condition that may substantially alter immune status.\n* Long-term use of immunosuppressive or other immunomodulatory medications, defined as continuous or intermittent use for a cumulative duration of at least 3 months.\n* A diagnosed coagulation abnormality or bleeding disorder, including coagulation factor deficiency, other coagulation disorders, or platelet abnormalities.\n* Any other condition that, in the investigator's judgment, makes the child unsuitable for participation.",true,"ALL","0 Days","7 Years",{"count":114,"type":115},1200,"ESTIMATED","OBSERVATIONAL","This prospective observational study will enroll approximately 1,200 children from birth through 7 years of age in Zhejiang Province, China. Participants will include general healthy children from the community, children with a history of serious or recurrent infections, and children with confirmed or highly suspected asthma. No treatment will be assigned by the researchers.\n\nHealth information will be collected through questionnaires, vaccination and medical records, regular follow-up, and active surveillance of respiratory infections. Blood, stool, and nasopharyngeal swab samples will be collected at enrollment and annual visits. Additional blood and respiratory samples will be collected during selected respiratory infection events.\n\nLaboratory assessments may include antibody, pathogen, microbiome, and single-cell analyses. The study aims to characterize biomarkers of anti-infective immunity in children and assess their risk of infection.\n\nXiamen University, Zhejiang Provincial Center for Disease Control and Prevention, and Xiang An Biomedicine Laboratory are the co-sponsors of this study. Hanqing He (Zhejiang Provincial CDC) and Tianying Zhang (Xiamen University) serve as the co-principal investigators.",[119,120,121],"Immunity","Respiratory Infection","Asthma",[123,124,125,126,127],"Childhood Immunity","Immune Development","Infectious Disease Surveillance","asthma","respiratory infection","NOT_YET_RECRUITING","2026-09-06",{"date":131,"type":132},"2026-09-11","ACTUAL",{"date":134,"type":115},"2026-09-10",{"date":136,"type":115},"2036-12-31",{"name":5,"class":6},2]