Lung DiseasesINSPIRE CHILDNCT06746077
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
An observational study of Lung Diseases, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Lung Diseases
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Apr 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Childrens Center for Pulmonary and Allergic diseases, Aarhus University Hospital
Aarhus N, 8200
About this study
Official title: INSPIRE CHILD: 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:
Read more
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
- Being tested
- No intervention
- Keywords
- Pediatric, Lung Disease, Microbiome, Cytokine, Inflammation, Immune Cell, Bacteria, Asthma, Coughing, Immunophenotype, Bronchiectasis, Bronchoscopy, BAL, Bronchoalveolar lavage, Diffuse Lung Disease, Interstitial Lung Disease
- Medical subject headings
- Lung Diseases, Inflammation, Asthma, Cough, Bronchiectasis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: Day 0 (Subsequent to study inclusion)
Secondary outcomes (3)
Concentration range for selected interleukins in BAL-fluid
Measured: Day 0 (Subsequent to study inclusion)
Lung disease association
Can we associate a specific profile of findings with a particular pediatric lung disease?
Measured: Through study completion, an average of 2 year
Clinical symptoms
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
Measured: 2 weeks prior to enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start30 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sune Rubak, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746077
- Sponsor's protocol ID
- VEK j.nr. 1-10-72-8-24
- Acronym
- INSPIRE CHILD
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data that underlie the results reported in study articles (text, tables, figures, and appendices). The laws related to the handling of personal data will be followed and results are processed in accordance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act (Databeskyttelsesforordningen and Databeskyttelsesloven).
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRE CHILD: Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children
- ClinicalTrials.gov ID
- NCT06746077
- Acronym / sponsor ID
- INSPIRE CHILD / VEK j.nr. 1-10-72-8-24
- Conditions
- Lung Diseases
- Keywords
- Pediatric, Lung Disease, Microbiome, Cytokine, Inflammation, Immune Cell, Bacteria, Asthma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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)
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
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymized data that underlie the results reported in study articles (text, tables, figures, and appendices). The laws related to the handling of personal data will be followed and results are processed in accordance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act (Databeskyttelsesforordningen and Databeskyttelsesloven).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines (time frame: Day 0 (Subsequent to study inclusion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.