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Clinical Trials in Denmark / NCT06746077
Enrolling by invitation Observational

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

NCT06746077 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aarhus University Hospital
Phase
Observational
Started
2024-04-30
Last updated
2024-12-24

Condition(s) studied

Lung Diseases

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
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.

Primary outcome measure(s)

  • Cytokines — Day 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)
  • Immunophenotype — Day 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 microbiome — Day 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.

Trial sites (1)

FacilityCityRegionStatus
Childrens Center for Pulmonary and Allergic diseases, Aarhus University Hospital Aarhus N Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06746077 on ClinicalTrials.gov ↗ ← All trials in Denmark