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Completed

NCT Number: NCT07118644

Microbiote's Evolution After Use of Nitrous Oxide on Pediatric Patient Needing Airway Samples

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.

Completed

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Key information

Age range

3 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brest, University Hospital

Brest, 29609, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

MEOPA

Drug

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 sputum

Other

Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. Oxygen will be used for nebulization.

Primary outcomes

  1. α and β diversities

    Time frame: Day 1

    These outcomes will be calculated from ASV table obtained from 16S metagenomic analysis.

Secondary outcomes

  1. Children anxiety

    Time frame: Day 1

    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)

  2. Feeling of physiotherapist about the child's behaviour

    Time frame: Day 1

    Likert scale after each induced sputum

  3. Feeling of parent(s) about the child's behaviour

    Time frame: Day 1

    Visual Analogue Scale (VAS) after each induced sputum

  4. Sputum induced adverse events

    Time frame: Day 5

    Number of adverse events related to induced expectoration

  5. Specimen quality

    Time frame: Day 1

    Murray and Washington cytological score (good quality specimen: score ≥ 3; poor quality specimen: score < 3)

  6. Search for microbiota mismatch with or without meopa

    Time frame: Day 1

    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

  7. Bacterial taxa

    Time frame: Day 1

    Bacterial taxa is identified by 16S v3-v4 targeted metagenomics.

  8. Adverse Events

    Time frame: Day 5

    Number of adverse events

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: MicroNO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
Jun 15, 2026

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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