Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age

Conditions
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Asthma

Intervention / Treatment
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* Device: Standard nebulizer
* Device: PARI LC Sprint Sp nebulizer


Participation Criteria
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Eligibility Criteria
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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) And / or CAS> 4/10 (after 3 attempted nebulized salbutamol sessions over 1 hour of emergency care). Exclusion Criteria: The patient is participating in another study The patients has already been included in this study a previous time The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The parent or legal representative refuses to sign the consent It is impossible to correctly inform the parent or legal representative The patient has a contra indication for a treatement used in this study Patient was born at < 34 weeks of pregnancy or bronchdysplasic First or second episode of bronchiolitis Asthma attack with CAS score ≤ 4/10 or inpatient basis for a non-breathing related motive. Acute severe Asthma attack: hypercapnia, impaired consciousness, need for hospitalization in intensive care, need for mechanical ventilation, need for salbutamol IV Patient with known congenital heart disease Patient with chronic respiratory disease other than asthma Patient with encephalopathy Patient with known immune deficiency CAS ≤ 2 and transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% when asleep for at least 12h

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard nubulizer<br>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. | Device: Standard nebulizer<br>* Nebulizer sessions for the patients will be administerd using our standard nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.<br>* Other names: Micro Mist Nebulizer;|
| Experimental: Experimental nebulizer<br>Nebulizer sessions for the patients in this arm will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany | Device: PARI LC Sprint Sp nebulizer<br>* Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | The length of hospitalization in days | hospital discharge (maximum of 10 days) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nebulizer, PARI LC Spring SP