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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518197-14-00 | EU Trial (CTIS) Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Experimental | Induced sputum with MEOPA |
|
| Control | Other | Standard induced sputum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| α and β diversities | These outcomes will be calculated from ASV table obtained from 16S metagenomic analysis. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Children anxiety | 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) | Day 1 |
| Feeling of physiotherapist about the child's behaviour |
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Inclusion Criteria:
Exclusion Criteria:
Contraindication of MEOPA :
Contraindications to induced expectoration :
Patient with minor parent(s)
Uncooperative child
Antibiotic therapy administered within the previous 24 hours.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest, University Hospital | Brest | 29609 | France |
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| ID | Term |
|---|---|
| C576493 | Meopa |
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This is an exploratory, controlled, open-label, prospective, monocentric clinicobiological case control study. Each case is its own control.
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| Standard induced sputum | Other | Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. Oxygen will be used for nebulization. |
|
Likert scale after each induced sputum |
| Day 1 |
| Feeling of parent(s) about the child's behaviour | Visual Analogue Scale (VAS) after each induced sputum | Day 1 |
| Sputum induced adverse events | Number of adverse events related to induced expectoration | Day 5 |
| Specimen quality | Murray and Washington cytological score (good quality specimen: score ≥ 3; poor quality specimen: score < 3) | Day 1 |
| Search for microbiota mismatch with or without meopa | 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 | Day 1 |
| Bacterial taxa | Bacterial taxa is identified by 16S v3-v4 targeted metagenomics. | Day 1 |
| Adverse Events | Number of adverse events | Day 5 |