Lung Microbiota’s evolution after use of Nitrous Oxide on pediatric patient needing airway samples - MicroNO

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

24 Sep 2025 → ongoing

Decision date (initial)

2025-02-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

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.

Secondary objectives 4

1. Determine the effect of MEOPA on the tolerance of the induced expectoration procedure, via an evaluation of the child, the MKDE practitioner and the parents.
2. Determine whether MEOPA improves sampling quality
3. Identification of potential adverse effects of induced expectoration
4. Comparison of ECBC with and without MEOPA (direct examination and culture)

Conditions and MedDRA coding

Pediatric respiratory disorder

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Children aged 3 months to 8 years
2. Patients requiring ECBC sampling in routine practice: acute respiratory distress with suspected lower respiratory infection (superinfected bronchiolitis or asthma attacks, suspected pneumonitis) and severe asthma
3. Free, informed and written consent from at least one of the minor's legal representatives
4. Affiliated to the social security system
5. Child unable to expectorate effectively

Exclusion criteria 5

1. Contraindication of MEOPA : - Patients requiring 100% oxygen ventilation - Intracranial hypertension - Altered state of consciousness preventing cooperation - Any condition where air is trapped́ inside the body and its expansion could be dangerous (cranial and/or maxillofacial trauma, pneumothorax, emphysema, gas embolism, following recent scuba diving, decompression accident, during middle ear/internal ear or sinus surgery, abdominal gas distension, if air is injected into the epidural space during epidural anesthesia, if the patient has received ophthalmic gas for as long as the gas bubble persists and up to 3 months afterwards) - Known, unsubstituted vitamin B12 or folic acid deficiency - Recent onset of unexplained neurological abnormalities.
2. Contraindications for induced expectoration: Clinical instability not conducive to induced expectoration (at practitioner's discretion) - Severe respiratory insufficiency, - Severe spasticity. - Hemoptysis - Decompensated heart failure - Contraindications to the use of hypertonic saline : o Hypersensitivity of the bronchial system to hypertonic sodium chloride solutions. o Hemoptysis. - Contraindication to the use of salbutamol o 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 to maneuvers performed by physiotherapists: bullous emphysema, confirmed hiatal or diaphragmatic hernia and rib fragility.
3. Patient with minor parent(s)
4. Antibiotic therapy administered within the previous 24 hours.
5. Uncooperative child

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pulmonary bacterial biodiversity assessed using quantitative indices such as alpha diversity and beta diversity calculated for good-quality respiratory samples

Secondary endpoints 5

1. Assessment of sputum tolerance induced by -The use of age-appropriate anxiety scores (mYPAS-SF, cf. appendix 2) -Likert scales to assess the MKDE practitioner's feelings (cf. Appendix 3) -A numerical scale from 0 to 10 to assess the parents' feelings
2. Quality of samples according to cytological score
3. Collection of adverse events
4. Difference between ECBC with and without MEOPA (direct examination, count and culture)
5. Catalog of bacterial taxa identified by 16S v3-v4 targeted metagenomics.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Et Universitaire De Brest

Sponsor organisation

Centre Hospitalier Regional Et Universitaire De Brest

Address

2 Avenue Marechal Foch

City

Brest

Postcode

29200

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Dr Pierrick CROS

Public contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Dr Pierrick CROS

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications