NCT01649401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3.9 years

First QC Date

July 23, 2012

Last Update Submit

January 31, 2017

Conditions

Asthma

Keywords

nebulizerPARI LC Spring SP

Outcome Measures

Primary Outcomes (1)

  • Length of hospitalization

    The length of hospitalization in days

    hospital discharge (maximum of 10 days)

Secondary Outcomes (46)

  • Duration of oxygen therapy

    Day 0

  • Heart rate before the first nebulisation session

    Day 0

  • Heart rate 30 minutes after the first nebulisation session

    Day 0

  • SpO2 saturation less thant 90% during or after nebulisation session?

    Day 0

  • Duration of oxygen therapy

    Day 1

  • +41 more secondary outcomes

Study Arms (2)

Standard nubulizer

ACTIVE COMPARATOR

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

Experimental nebulizer

EXPERIMENTAL

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

Interventions

Standard nebulizerDEVICE

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

Also known as: Micro Mist Nebulizer
Standard nubulizer
PARI LC Sprint Sp nebulizerDEVICE

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

Experimental nebulizer

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • The patient is participating in another study
  • The patients has already been included in this study a previous time
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lucie Gilton-Bott, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 25, 2012

Study Start

December 1, 2012

Primary Completion

November 4, 2016

Study Completion

November 4, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

FR(1)