Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3% hypertonic saline
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Hypertonic saline solution, bronchiolitis, RSV
Eligibility Criteria
Inclusion Criteria:
- infants less than 24 months of age with first episode of wheezing.
Exclusion Criteria:
- age>24 months,
- previous episode of wheezing,
- chronic cardiac and pulmonary disease,
- immunodeficiency,
- accompanying respiratory failure,
- requiring mechanical ventilation,
- inhaling the nebulized 3% hypertonic saline solution 12 hours before treatment,
- premature infants born at less than 34 weeks gestation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
hypertonic saline
normal saline (NS)
Arm Description
hypertonic saline (HS)
normal saline (NS)
Outcomes
Primary Outcome Measures
To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS.
Secondary Outcome Measures
To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
evaluated for the hoarse voice, vomiting, diarrhea, general condition
Full Information
NCT ID
NCT01120496
First Posted
April 23, 2010
Last Updated
May 10, 2010
Sponsor
Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01120496
Brief Title
Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
Official Title
A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is planned to investigate whether frequently inhaled hypertonic saline (HS) can relieve symptoms and signs faster than normal saline (NS) and shorten length of stay (LOS) significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.
Detailed Description
The treatment of bronchiolitis remains largely supportive with mechanical ventilatory support as needed .Other types of treatment remain controversial.We and other researchers have demonstrated that nebulized HS and bronchodilators decreased symptoms and LOS for infants with mild to moderate viral bronchiolitis .All the aforementioned studies used 3 times per day dosing, which is significantly less than the 3 to 6 times per hour regimens often used in children in respiratory distress.Frequently nebulized HS reduced the LOS for infants with moderately severe bronchiolitis.The present study is planned to investigate whether frequently inhaled HS can relieve symptoms and signs faster than NS and shorten LOS significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.
PMID: 15266547 PMID: 12576370 PMID: 16599051 PMID: 17719935 PMID: 20014350 PMID: 12475841
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Hypertonic saline solution, bronchiolitis, RSV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypertonic saline
Arm Type
Experimental
Arm Description
hypertonic saline (HS)
Arm Title
normal saline (NS)
Arm Type
Placebo Comparator
Arm Description
normal saline (NS)
Intervention Type
Drug
Intervention Name(s)
3% hypertonic saline
Other Intervention Name(s)
normal saline
Intervention Description
Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
3% hypertonic saline
Intervention Description
Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline
Primary Outcome Measure Information:
Title
To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
Description
Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
Description
evaluated for the hoarse voice, vomiting, diarrhea, general condition
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infants less than 24 months of age with first episode of wheezing.
Exclusion Criteria:
age>24 months,
previous episode of wheezing,
chronic cardiac and pulmonary disease,
immunodeficiency,
accompanying respiratory failure,
requiring mechanical ventilation,
inhaling the nebulized 3% hypertonic saline solution 12 hours before treatment,
premature infants born at less than 34 weeks gestation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhengxiu luo, doctor
Organizational Affiliation
Chongqing Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.gov
Description
Related Info
Learn more about this trial
Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
We'll reach out to this number within 24 hrs