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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00629-34 | Other Identifier | RCB |
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The main objective of this study is to determine whether the use of the PARI LC Sprint Sp nebulizer in the treatment of asthma in children under 36 months reduces the duration of hospitalization.
The secondary objectives of this study are to evaluate whether the use of the LC Sprint Sp Nebulizer results in:
A-shortened duration of oxygen-dependence.
B-reduced side effects by assessing the patient's heart rate before and 30 minutes after the first aerosol and noting the occurrence of desaturation <90% during the nebulisation sessions.
C-increased acceptance of the aerosol, measured via a questionnaire given to the patient's parents at the end of hospitalization (a single questionnaire will be completed by either parent or both parents).
D-shortened length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score (CAS)) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% during sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard nubulizer | Active Comparator | Nebulizer sessions for the patients in this arm will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical. |
|
| Experimental nebulizer | Experimental | Nebulizer sessions for the patients in this arm will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard nebulizer | Device | Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospitalization | The length of hospitalization in days | hospital discharge (maximum of 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 0 |
| Heart rate before the first nebulisation session |
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Inclusion Criteria:
The parent or legal representative must have given his/her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
The patient has an attack of moderate to severe asthma (at least the third episode of wheezing dyspnea since birth) requiring hospitalization defined by the following criteria:
requires oxygen: SpO2 <92% on room air (if CAS ≤ 4/10)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucie Gilton-Bott, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| PARI LC Sprint Sp nebulizer | Device | Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany |
|
Heart rate before the first nebulisation session (bpm)
| Day 0 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 0 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 0 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 1 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 2 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 3 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 4 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 5 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 6 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 7 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 8 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 9 |
| Duration of oxygen therapy | Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours | Day 10 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 1 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 2 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 3 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 4 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 5 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 6 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 7 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 8 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 9 |
| Heart rate before the first nebulisation session | Heart rate before the first nebulisation session (bpm) | Day 10 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 1 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 2 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 3 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 4 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 5 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 6 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 7 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 8 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 9 |
| Heart rate 30 minutes after the first nebulisation session | Heart rate 30 minutes after the first nebulisation session (bpm) | Day 10 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 1 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 2 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 3 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 4 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 5 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 6 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 7 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 8 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 9 |
| SpO2 saturation less thant 90% during or after nebulisation session? | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) | Day 10 |
| Parent estimated tolerance | A visual analog scale is used to evaluate how parents estimate aerosol tolerance. | Hospital discharge (maximum 10 days) |
| Length of hospitalization according to discharge criteria | length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score CAS) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% during sleep | Hospital discharge (maximum 10 days) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |