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

NCT07118644 | Not Yet Recruiting Phase 3

• 2 other identifiers: 29BRC23.02382024-518197-14-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. Children aged 3 months to 8 years and they requiring ECBC sampling in routine practice.

Conditions

Respiratory Ilness; Children

Keywords

Lung microbiota; MEOPA; Infant

Outcome Measures

Primary Outcomes (1)

• α and β diversities

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

  Day 1

Secondary Outcomes (8)

• Children anxiety

  Day 1

• Feeling of physiotherapist about the child's behaviour

  Day 1

• Feeling of parent(s) about the child's behaviour

  Day 1

• Sputum induced adverse events

  Day 5

• Specimen quality

  Day 1

Study Arms (2)

Case

EXPERIMENTAL

Induced sputum with MEOPA

Drug: MEOPA

Control

OTHER

Standard induced sputum

Other: Standard induced sputum

Interventions

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.

Case

Standard induced sputum OTHER

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

Control

Eligibility Criteria

• Age: 3 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Brest, University Hospital

Brest, 29609, France

Location

MeSH Terms

Interventions

Meopa

Central Study Contacts

Pierrick CROS, MD

CONTACT

+33298223659; pierrick.cros@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an exploratory, controlled, open-label, prospective, monocentric clinicobiological case control study. Each case is its own control.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 6, 2027
• Study Completion (Estimated): September 6, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

FR (1)