Clinical trial NCT01649401: Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
Official title: Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: nebulizer
PARI LC Spring SP
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospitalization
timeFrame: hospital discharge (maximum of 10 days)
Secondary outcomes:
measure: Duration of oxygen therapy
timeFrame: Day 0
measure: Heart rate before the first nebulisation session
timeFrame: Day 0
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 0
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 0
measure: Duration of oxygen therapy
timeFrame: Day 1
measure: Duration of oxygen therapy
timeFrame: Day 2
measure: Duration of oxygen therapy
timeFrame: Day 3
measure: Duration of oxygen therapy
timeFrame: Day 4
measure: Duration of oxygen therapy
timeFrame: Day 5
measure: Duration of oxygen therapy
timeFrame: Day 6
measure: Duration of oxygen therapy
timeFrame: Day 7
measure: Duration of oxygen therapy
timeFrame: Day 8
measure: Duration of oxygen therapy
timeFrame: Day 9
measure: Duration of oxygen therapy
timeFrame: Day 10
measure: Heart rate before the first nebulisation session
timeFrame: Day 1
measure: Heart rate before the first nebulisation session
timeFrame: Day 2
measure: Heart rate before the first nebulisation session
timeFrame: Day 3
measure: Heart rate before the first nebulisation session
timeFrame: Day 4
measure: Heart rate before the first nebulisation session
timeFrame: Day 5
measure: Heart rate before the first nebulisation session
timeFrame: Day 6
measure: Heart rate before the first nebulisation session
timeFrame: Day 7
measure: Heart rate before the first nebulisation session
timeFrame: Day 8
measure: Heart rate before the first nebulisation session
timeFrame: Day 9
measure: Heart rate before the first nebulisation session
timeFrame: Day 10
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 1
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 2
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 3
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 4
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 5
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 6
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 7
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 8
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 9
measure: Heart rate 30 minutes after the first nebulisation session
timeFrame: Day 10
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 1
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 2
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 3
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 4
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 5
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 6
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 7
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 8
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 9
measure: SpO2 saturation less thant 90% during or after nebulisation session?
timeFrame: Day 10
measure: Parent estimated tolerance
timeFrame: Hospital discharge (maximum 10 days)
measure: Length of hospitalization according to discharge criteria
timeFrame: Hospital discharge (maximum 10 days)
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Lucie Gilton-Bott, MD
role: PRINCIPAL_INVESTIGATOR
References: