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

NCT06746077 | Enrolling By Invitation

• 1 other identifier: VEK j.nr. 1-10-72-8-24
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (3)

• Concentration range for selected interleukins in BAL-fluid

  Day 0 (Subsequent to study inclusion)

• Lung disease association

  Through study completion, an average of 2 year

• Clinical symptoms

  2 weeks prior to enrollment

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Childrens Center for Pulmonary and Allergic diseases, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Lung Diseases; Inflammation; Asthma; Cough; Bronchiectasis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Associate Professor

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: December 24, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the study has been finalized.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

DK (1)