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Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.

INSPIRE CHILD: Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06746077
Acronym
INSPIRE CHILD
Enrollment
200
Registered
2024-12-24
Start date
2024-04-30
Completion date
2027-12-31
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

Keywords

Pediatric, Lung Disease, Microbiome, Cytokine, Inflammation, Immune Cell, Bacteria, Asthma, Coughing, Immunophenotype, Bronchiectasis, Bronchoscopy, BAL, Bronchoalveolar lavage, Diffuse Lung Disease, Interstitial Lung Disease

Brief summary

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Age ranging from new-born to 17 years of age. * Diagnosed with or being assessed for a lung disease. * Possible to sample at least 2 ml of BAL-fluid besides the scheduled amount during the bronchoscopy.

Exclusion criteria

* Age older than 17 years. * Not undergoing diagnosis at Childrens Center for Pulmonary and Allergic diseases. * Failure to meet the requirement of being able to sample an additional 2 ml of BAL-fluid.

Design outcomes

Primary

MeasureTime frameDescription
CytokinesDay 0 (Subsequent to study inclusion)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)
ImmunophenotypeDay 0 (Subsequent to study inclusion)Using flow cytometry to investigate immune cells: e.g. Neutrophils, Eosinophils, Monocytes, NK-cells, B-cells, CD4+-T-cells, CD8+-T-cells
Lung microbiomeDay 0 (Subsequent to study inclusion)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.

Secondary

MeasureTime frameDescription
Concentration range for selected interleukins in BAL-fluidDay 0 (Subsequent to study inclusion)
Lung disease associationThrough study completion, an average of 2 yearCan we associate a specific profile of findings with a particular pediatric lung disease?
Clinical symptoms2 weeks prior to enrollment2 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026