NCT07118644

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 3 Months – 8 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	MEOPA	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.
OTHER	Standard induced sputum	Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. Oxygen will be used for nebulization.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-06
• Completion: 2027-09-06
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: France