NCT07815925Not yet recruiting
Childhood Infection and Immunity Longitudinal Cohort
Childhood Infection and Immunity Longitudinal Cohort (KIDTRACE)
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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. Health 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. Laboratory 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. Xiamen 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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- 10 Sept 2026
- Primary completion date
- 31 Dec 2036
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Diseases
- Asthma
- NCT number
- NCT07815925
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 10 Sept 2026 to the primary completion date, 31 Dec 2036
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- An acute illness within 14 days before enrollment, including respiratory, gastrointestinal, dermatologic, or urinary symptoms or conditions specified in the protocol.
- Long-term use of immunosuppressive or other immunomodulatory medications, defined as continuous or intermittent use for a cumulative duration of at least 3 months.
Other illness
- Known primary immunodeficiency, malignant tumor, serious congenital disorder, or another condition that may substantially alter immune status.
- Any other condition that, in the investigator's judgment, makes the child unsuitable for participation.
Lab values
- A diagnosed coagulation abnormality or bleeding disorder, including coagulation factor deficiency, other coagulation disorders, or platelet abnormalities.
Who the study is looking for
- Children from birth through 7 years of age (younger than 8 years at enrollment).
- The participant's parent or legal guardian is able to understand the study, voluntarily agrees to participation, and provides written informed consent.
- The participant resides in the study area and is expected to be available for long-term follow-up.
- For the General Community Cohort: no known serious underlying disease before enrollment.
- 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.
- 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.
Age in the registry: 0 days to 7 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dongyang Center for Disease Control and Prevention Coordinator of this site? Confirm its status | Dongyang | China | Unknown status |
| Yiwu Center for Disease Control and Prevention Coordinator of this site? Confirm its status | Yiwu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.