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Enrolling by Invitation

NCT Number: NCT06746077

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

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.

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Key information

Conditions

Lung Diseases Asthma Bronchial Diseases Bronchiectasis Cough Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation Lung Diseases, Interstitial Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Center for Pulmonary and Allergic diseases, Aarhus University Hospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Cytokines

    Time frame: 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)

  2. Immunophenotype

    Time frame: 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

  3. Lung microbiome

    Time frame: 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.

Secondary outcomes

  1. Concentration range for selected interleukins in BAL-fluid

    Time frame: Day 0 (Subsequent to study inclusion)

  2. Lung disease association

    Time frame: Through study completion, an average of 2 year

    Can we associate a specific profile of findings with a particular pediatric lung disease?

  3. Clinical symptoms

    Time frame: 2 weeks prior to enrollment

    2 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Acronym: INSPIRE CHILD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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