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

NCT ID: NCT01649401

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-11-04

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard nubulizer

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.

Group Type: ACTIVE_COMPARATOR

Standard nebulizer

Intervention Type: DEVICE

Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.

Experimental nebulizer

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

Manufacturer: PARI GmbH Germany

Group Type: EXPERIMENTAL

PARI LC Sprint Sp nebulizer

Intervention Type: DEVICE

Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer.

Manufacturer: PARI GmbH Germany

Interventions

Standard nebulizer

Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.

Intervention Type: DEVICE

PARI LC Sprint Sp nebulizer

Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer.

Manufacturer: PARI GmbH Germany

Intervention Type: DEVICE

Other Intervention Names

Micro Mist Nebulizer

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucie Gilton-Bott, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2012-A00629-34

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2012/LG-02

Identifier Type: -

Identifier Source: org_study_id