Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Lung Diseases. Basic parameters: 0 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
INSPIRE CHILD: Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children
Overview
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
- Other No intervention
No intervention
Primary outcome measures
- Cytokines [Time frame: Day 0 (Subsequent to study inclusion)]
- Immunophenotype [Time frame: Day 0 (Subsequent to study inclusion)]
- Lung microbiome [Time frame: Day 0 (Subsequent to study inclusion)]
Secondary outcome measures (3)
- Concentration range for selected interleukins in BAL-fluid [Time frame: Day 0 (Subsequent to study inclusion)]
- Lung disease association [Time frame: Through study completion, an average of 2 year]
- Clinical symptoms [Time frame: 2 weeks prior to enrollment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Childrens Center for Pulmonary and Allergic diseases, Aarhus University Hospital — Aarhus N
Identifiers
NCT: NCT06746077 · VEK j.nr. 1-10-72-8-24