Clinical trial NCT06746077: Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Official title: INSPIRE CHILD: Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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 outcomes:
measure: Cytokines
timeFrame: Day 0 (Subsequent to study inclusion)
measure: Immunophenotype
timeFrame: Day 0 (Subsequent to study inclusion)
measure: Lung microbiome
timeFrame: Day 0 (Subsequent to study inclusion)
Secondary outcomes:
measure: Concentration range for selected interleukins in BAL-fluid
timeFrame: Day 0 (Subsequent to study inclusion)
measure: Lung disease association
timeFrame: Through study completion, an average of 2 year
measure: Clinical symptoms
timeFrame: 2 weeks prior to enrollment
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Childrens Center for Pulmonary and Allergic diseases, Aarhus University Hospital
Study officials:
References: