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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Standard nebulizer; Device: PARI LC Sprint Sp nebulizer

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Standard nebulizer; Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.; Other Names: Micro Mist Nebulizer
Experimental: Experimental nebulizer; 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; Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Lucie Gilton-Bott, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): November 4, 2016
• Study Completion (Actual): November 4, 2016

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: nebulizer; PARI LC Spring SP
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: LOCAL/2012/LG-02; 2012-A00629-34 (Other Identifier: RCB)