Brest, University Hospital
Brest, 29609, France
NCT Number: NCT07118644
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.
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Notify Me3 month–8 year
All sexes
Interventional
Phase 3
Brest, 29609, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. Oxygen will be used for nebulization.
Time frame: Day 1
These outcomes will be calculated from ASV table obtained from 16S metagenomic analysis.
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)
Time frame: Day 1
Likert scale after each induced sputum
Time frame: Day 1
Visual Analogue Scale (VAS) after each induced sputum
Time frame: Day 5
Number of adverse events related to induced expectoration
Time frame: Day 1
Murray and Washington cytological score (good quality specimen: score ≥ 3; poor quality specimen: score < 3)
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
Time frame: Day 1
Bacterial taxa is identified by 16S v3-v4 targeted metagenomics.
Time frame: Day 5
Number of adverse events
University Hospital, Brest
Other
Acronym: MicroNO
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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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