Respiratory IlnessPhase 3MicroNONCT07118644
Microbiote's Evolution After Use of Nitrous Oxide on Pediatric Patient Needing Airway Samples
A Phase 3 study testing MEOPA and Standard induced sputum in people with Respiratory Ilness and Children, run by University Hospital, Brest at 1 site in France.
Trial summary
The objective of this study is to determine whether the use of MEOPA alters the composition of respiratory microbiota collected by induced sputum in children requiring respiratory sampling for suspected lower respiratory tract infection. Read more about this study
- Who is it for?
- Ages 3 months to 8 years
- Conditions the study is for
- Respiratory Ilness, Children
- What is being tested?
- MEOPA and Standard induced sputum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2025to 23 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 3 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged from 3 months to 8 years old
- Patients requiring ECBC in routine practice: acute respiratory distress with suspected bacterial respiratory infection (superinfected bronchiolitis or asthma attack, suspected pneumonia) and severe asthma assessment
- Child unable to expectorate effectively
- Free, informed and written consent of the minor patient's legal guardians;
- Enrolled in the social security system.
Who cannot join
- Contraindication of MEOPA :
- Patients requiring 100% oxygen ventilation
- Intracranial hypertension
- Altered state of consciousness preventing cooperation
- Any condition where air is trapped inside the body and expansion could be dangerous (cranial and/or maxillofacial trauma, pneumothorax, emphysema, gas embolism, following recent scuba diving, decompression sickness following gas encephalography, during middle ear/internal ear or sinus surgery, abdominal gas distension, when air is injected into the epidural space during epidural anesthesia, if the patient has received ophthalmic gas (SF6, C3F8, C2F6) used in eye surgery for as long as the gas bubble persists and up to 3 months afterwards)
- Known, unsubstituted vitamin B12 or folic acid deficiency
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- Recent, unexplained neurological abnormalities
- Contraindications to induced expectoration :
- Clinical instability not conducive to induced expectoration (at practitioner's discretion)
- Severe respiratory insufficiency,
- Severe spasticity.
- Hemoptysis
- Decompensated heart failure
- Contraindication of hypertonic saline :
- Hypersensitivity of the bronchial system to hypertonic sodium chloride solutions.
- Hemoptysis
- Contraindication to the use of Salbutamol :
- Hypersensitivity to any of the constituents of salbutamol-based pressurized or inhaled products.
- Intolerance to salbutamol-based pressurized or inhaled products (coughing or bronchospasm occurring immediately after inhalation of the product).
- Contraindication of the maneuver performed by the physiotherapist: bullous emphysema, confirmed hiatal or diaphragmatic hernia and rib fragility.
- Patient with minor parent(s)
- Uncooperative child
- Antibiotic therapy administered within the previous 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine whether the use of MEOPA alters the composition of respiratory microbiota collected by induced sputum in children requiring respiratory sampling for suspected lower respiratory tract infection.
Children aged 3 months to 8 years and they requiring ECBC sampling in routine practice.
Read the detailed description
This is an exploratory, controlled, open-label, prospective, monocentric clinicobiological case control study. Each case is its own control. A sample will be taken without MEOPA and then with MEOPA.
The Infants will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Cytological and microbiological analyses are carried out on each sample.
- Conditions
- Respiratory Ilness, Children
- Being tested
- MEOPA, Standard induced sputum
- Keywords
- Lung microbiota, MEOPA, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEOPADrug
Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. MEOPA will be used for nebulization. MEOPA is a gas with analgesic, amnesic and anxiolytic properties.
Standard induced sputumOther
Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. Oxygen will be used for nebulization.
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | Induced sputum with MEOPA Receives: Drug: MEOPA |
| Control | Other | Standard induced sputum Receives: Other: Standard induced sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
α and β diversities
These outcomes will be calculated from ASV table obtained from 16S metagenomic analysis.
Measured: Day 1
Secondary outcomes (8)
Children anxiety
mYPAS-SF (Modified Yale Preoperative Anxiety Scale, short version) total score before and after each induced sputum. Score between 4 and 18 (18 is the maximum level of anxiety)
Measured: Day 1
Feeling of physiotherapist about the child's behaviour
Likert scale after each induced sputum
Measured: Day 1
Feeling of parent(s) about the child's behaviour
Visual Analogue Scale (VAS) after each induced sputum
Measured: Day 1
Sputum induced adverse events
Number of adverse events related to induced expectoration
Measured: Day 5
Specimen quality
Murray and Washington cytological score (good quality specimen: score ≥ 3; poor quality specimen: score < 3)
Measured: Day 1
Search for microbiota mismatch with or without meopa
The criterion is defined by an expert opinion indicating whether the results of the examinations are concordant, or discordant against MEOPA or discordant in favor of MEOPA
Measured: Day 1
Bacterial taxa
Bacterial taxa is identified by 16S v3-v4 targeted metagenomics.
Measured: Day 1
Adverse Events
Number of adverse events
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start24 Sep 2025
- Primary completion17 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory IlnessStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is an exploratory, controlled, open-label, prospective, monocentric clinicobiological case control study. Each case is its own control.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118644
- Sponsor's protocol ID
- 29BRC23.0238
- Other IDs
- 2024-518197-14-00
- Acronym
- MicroNO
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiote's Evolution After Use of Nitrous Oxide on Pediatric Patient Needing Airway Samples
- ClinicalTrials.gov ID
- NCT07118644
- Acronym / sponsor ID
- MicroNO / 29BRC23.0238
- Conditions
- Respiratory Ilness, Children
- Keywords
- Lung microbiota, MEOPA, Infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 12 Aug 2025 (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 objective of this study is to determine whether the use of MEOPA alters the composition of respiratory microbiota collected by induced sputum in children requiring respiratory sampling for suspected lower respiratory tract infection.
Children aged 3 months to 8 years and they requiring ECBC sampling in routine practice.
Detailed description
This is an exploratory, controlled, open-label, prospective, monocentric clinicobiological case control study. Each case is its own control. A sample will be taken without MEOPA and then with MEOPA.
The Infants will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Cytological and microbiological analyses are carried out on each sample.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an exploratory, controlled, open-label, prospective, monocentric clinicobiological case control study. Each case is its own control.
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Drug: MEOPAInduced sputum with MEOPA |
| Control | Other | Other: Standard induced sputumStandard induced sputum |
Who may qualify
- Ages
- 3 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged from 3 months to 8 years old
- Patients requiring ECBC in routine practice: acute respiratory distress with suspected bacterial respiratory infection (superinfected bronchiolitis or asthma attack, suspected pneumonia) and severe asthma assessment
- Child unable to expectorate effectively
- Free, informed and written consent of the minor patient's legal guardians;
- Enrolled in the social security system.
Key exclusion criteria (23 listed)
- Contraindication of MEOPA :
- Contraindications to induced expectoration :
- Patient with minor parent(s)
- Uncooperative child
- Antibiotic therapy administered within the previous 24 hours.
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 |
|---|---|---|
| MEOPAInduced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. MEOPA will be used for nebulization. MEOPA is a gas with analgesic, amnesic and anxiolytic properties. | Drug | Case |
| Standard induced sputumInduced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. Oxygen will be used for nebulization. | Other | Control |
Primary outcome
α and β diversities
Time frame: Day 1
These outcomes will be calculated from ASV table obtained from 16S metagenomic analysis.
8 secondary outcomes
Children anxiety
Time frame: Day 1
Feeling of physiotherapist about the child's behaviour
Time frame: Day 1
Feeling of parent(s) about the child's behaviour
Time frame: Day 1
Sputum induced adverse events
Time frame: Day 5
Specimen quality
Time frame: Day 1
Search for microbiota mismatch with or without meopa
Time frame: Day 1
Bacterial taxa
Time frame: Day 1
Adverse Events
Time frame: Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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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. This study is not recruiting at the moment.
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?
A Phase 3 study testing MEOPA and Standard induced sputum in people with Respiratory Ilness and Children, run by University Hospital, Brest at 1 site in France.
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 5 inclusion and 23 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: finished, as of the sponsor's last update on 15 Jun 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
α and β diversities (time frame: Day 1). 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 15 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.