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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Asthma

Treatments: Device: Standard nebulizer; Device: PARI LC Sprint Sp nebulizer

Study type: Interventional

Funder types: Other

Identifiers

NCT01649401

2012-A00629-34 (Other Identifier)

LOCAL/2012/LG-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 6 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Standard nubulizer

Active Comparator group

Description:

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.

Treatment:

Device: Standard nebulizer

Experimental nebulizer

Experimental group

Description:

Nebulizer sessions for the patients in this arm will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany

Treatment:

Device: PARI LC Sprint Sp nebulizer