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The INSPIRE CHILD-study is a clinical research project focused on understanding lung diseases in children. The study aims to explore how the presence of certain bacteria, immune responses, and inflammatory markers in the lungs are connected to different lung diseases in pediatric patients.
Background:
Lung diseases in children can have long-lasting effects on their health, not only during childhood but also as they grow into adults. However, the specific causes and mechanisms behind these diseases are not yet fully understood. The INSPIRE CHILD-study is designed to investigate whether children with various lung conditions have distinct differences in the types of bacteria, immune system activity, and inflammation in their lungs.
Hypothesis:
Different lung diseases in children are hypothesized to be associated with unique patterns of bacteria, immune responses, and inflammation in the lungs By studying these patterns, the investigators hope to gain new insights that could lead to better diagnostic tools and more personalized treatments for children suffering from lung diseases.
Children already scheduled to undergo bronchoscopy are included in the study. A small sample of fluid from the lungs is collected, and the sample is analyzed for bacteria, immune markers, and signs of inflammation. This research could pave the way for improved care and treatment for young patients with lung conditions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokines | Legendplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha) | Day 0 (Subsequent to study inclusion) |
| Immunophenotype | Using flow cytometry to investigate immune cells: e.g. Neutrophils, Eosinophils, Monocytes, NK-cells, B-cells, CD4+-T-cells, CD8+-T-cells | Day 0 (Subsequent to study inclusion) |
| Lung microbiome | We seek to investigate whether it is feasible to map the microbiome, virome and mycobiome of the pediatric lung from BAL-fluid. The study will investigate and report findings of bioinformatics analysis. | Day 0 (Subsequent to study inclusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration range for selected interleukins in BAL-fluid | Day 0 (Subsequent to study inclusion) | |
| Lung disease association | Can we associate a specific profile of findings with a particular pediatric lung disease? |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 200 children/adolescents with lung disease undergo bronchoscopy yearly at Childrens Center for Pulmonary and Allergic diseases, Aarhus University Hospital. All patients are on clinical indication already scheduled for bronchoscopy and BAL. Participants are recruited from this group of patients if they comply with the inclusion/exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Center for Pulmonary and Allergic diseases, Aarhus University Hospital | Aarhus N | 8200 | Denmark |
Anonymized data that underlie the results reported in study articles (text, tables, figures, and appendices).
The laws related to the handling of personal data will be followed and results are processed in accordance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act (Databeskyttelsesforordningen and Databeskyttelsesloven).
After the study has been finalized.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D007249 | Inflammation |
| D001249 | Asthma |
| D003371 | Cough |
| D001987 | Bronchiectasis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
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Bronchoalveolar lavage (BAL)-samples will be collected as well as a blood sample.
Both are kept in storage in a biobank for further research projects.
| Through study completion, an average of 2 year |
| Clinical symptoms | 2 weeks prior to date of inclusion/bronchoscopy, the subjects medical history is reviewed for the following: Characterization of cough Respiratory distress Functional limitations (due to respiratory distress) (acc. to age) Fever (temperature above 38.0 C) Breath sounds Urgent need for medication | 2 weeks prior to enrollment |
| D008173 | Lung Diseases, Obstructive |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |