Back to resultsModerate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations
Primary Purpose
Moderate to Severe Bronchiolitis
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
NaCl 3%
Standard therapy
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Bronchiolitis focused on measuring Bronchiolitis, Moderate to Severe, Hypertonic saline, NaCl 3% inhalations, Standard therapy, Wang score, in-patients
Eligibility Criteria
Inclusion Criteria:
- children between ages 6 weeks to 24 months
- first episode of wheezing
- diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score
Exclusion Criteria:
- Children with mild bronchiolitis (Wang score < 5)
- Children with pre-existent cardiac disease
- Children with clinically significant chronic respiratory disease
- Immunocompromised children
- Children with a gestational age at birth less than 34 weeks
- Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy)
- Children who received corticosteroid in any form in the preceding 2 weeks before presentation
- Children who received bronchodilators within 24 hours before presentation
- Children with critical illness at presentation requiring immediate admission to intensive care unit
Sites / Locations
- Hôpital de l'Enfance
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
NaCl 3% inhalations + standard therapy
Standard therapy
Arm Description
In this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy. Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed.
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed
Outcomes
Primary Outcome Measures
length of hospital stay
The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge.
Secondary Outcome Measures
transfer rate to ICU
readmission rate in the next 7 days following discharge
Wang clinical severity score evolution
adverse events
Patients' ability to feed
Full Information
NCT ID
NCT01812525
First Posted
March 14, 2013
Last Updated
August 17, 2016
Sponsor
Raphaelle Jaquet-Pilloud
Collaborators
Swiss Foundation for the Health of Children and Adolescents
1. Study Identification
Unique Protocol Identification Number
NCT01812525
Brief Title
Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations
Official Title
Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raphaelle Jaquet-Pilloud
Collaborators
Swiss Foundation for the Health of Children and Adolescents
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.
Detailed Description
Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial.
Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Bronchiolitis
Keywords
Bronchiolitis, Moderate to Severe, Hypertonic saline, NaCl 3% inhalations, Standard therapy, Wang score, in-patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NaCl 3% inhalations + standard therapy
Arm Type
Active Comparator
Arm Description
In this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy.
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed.
Arm Title
Standard therapy
Arm Type
Placebo Comparator
Arm Description
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed
Intervention Type
Drug
Intervention Name(s)
NaCl 3%
Other Intervention Name(s)
Mucoclear 3%
Intervention Description
NaCl 3%: 4ml QID
Intervention Type
Other
Intervention Name(s)
Standard therapy
Intervention Description
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed
Primary Outcome Measure Information:
Title
length of hospital stay
Description
The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
transfer rate to ICU
Time Frame
2 years
Title
readmission rate in the next 7 days following discharge
Time Frame
2 years
Title
Wang clinical severity score evolution
Time Frame
2 years
Title
adverse events
Time Frame
2 years
Title
Patients' ability to feed
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children between ages 6 weeks to 24 months
first episode of wheezing
diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score
Exclusion Criteria:
Children with mild bronchiolitis (Wang score < 5)
Children with pre-existent cardiac disease
Children with clinically significant chronic respiratory disease
Immunocompromised children
Children with a gestational age at birth less than 34 weeks
Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy)
Children who received corticosteroid in any form in the preceding 2 weeks before presentation
Children who received bronchodilators within 24 hours before presentation
Children with critical illness at presentation requiring immediate admission to intensive care unit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Yves Pauchard
Organizational Affiliation
Hôpital de l'Enfance, Lausanne, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital de l'Enfance
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1000
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
31488402
Citation
Jaquet-Pilloud R, Verga ME, Russo M, Gehri M, Pauchard JY. Nebulised hypertonic saline in moderate-to-severe bronchiolitis: a randomised clinical trial. Arch Dis Child. 2020 Mar;105(3):236-240. doi: 10.1136/archdischild-2019-317160. Epub 2019 Sep 5.
Results Reference
derived
Learn more about this trial
Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations
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