Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis
Primary Purpose
Acute Viral Bronchiolitis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nebulisations
Sponsored by
About this trial
This is an interventional prevention trial for Acute Viral Bronchiolitis
Eligibility Criteria
Inclusion Criteria:
- Infant of less than 18 months old
- infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\or crépitants in a viral context (head cold and\or cough and\or fever and\or notion of contage)
- Necessity of an clinical score upper to 4. This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points.
- absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care
- signature of the Informed consent
- Membership in a national insurance
Exclusion Criteria:
- Refusal of the parents to participate in the study
- 18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than 4.
- signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas
- histories of bronchiolitis or asthma of the infant
- cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age.
- child having set within 6 hours preceding the inclusion a treatment by bronchodilatateurs or corticoids by systematic or inhaled way.
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
conventional jet-nebulizer
a jet-nebulizer adapted for infants
a mesh-nebulizer adapted for infants
Arm Description
(particles diameter of 4-5 µm)
(particles diameter of 2-2.5 µm),
(particles diameter of 2-2.5 µm).
Outcomes
Primary Outcome Measures
the improvement of the clinical score of severity at the 48th hour between the 3 groups of children
Secondary Outcome Measures
the number of children requiring oxygen
tolerance of the nebulisations
the number of complications.
the number of parenteral nutrition
Full Information
NCT ID
NCT01295398
First Posted
February 9, 2011
Last Updated
August 28, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01295398
Brief Title
Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis
Official Title
Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Viral Bronchiolitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional jet-nebulizer
Arm Type
Other
Arm Description
(particles diameter of 4-5 µm)
Arm Title
a jet-nebulizer adapted for infants
Arm Type
Experimental
Arm Description
(particles diameter of 2-2.5 µm),
Arm Title
a mesh-nebulizer adapted for infants
Arm Type
Experimental
Arm Description
(particles diameter of 2-2.5 µm).
Intervention Type
Device
Intervention Name(s)
nebulisations
Primary Outcome Measure Information:
Title
the improvement of the clinical score of severity at the 48th hour between the 3 groups of children
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the number of children requiring oxygen
Time Frame
12 months
Title
tolerance of the nebulisations
Time Frame
12 months
Title
the number of complications.
Time Frame
12 months
Title
the number of parenteral nutrition
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infant of less than 18 months old
infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\or crépitants in a viral context (head cold and\or cough and\or fever and\or notion of contage)
Necessity of an clinical score upper to 4. This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points.
absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care
signature of the Informed consent
Membership in a national insurance
Exclusion Criteria:
Refusal of the parents to participate in the study
18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than 4.
signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas
histories of bronchiolitis or asthma of the infant
cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age.
child having set within 6 hours preceding the inclusion a treatment by bronchodilatateurs or corticoids by systematic or inhaled way.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis
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