Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
1 other identifier
interventional
135
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
May 11, 2010
CompletedMay 11, 2010
November 1, 2008
1 year
April 23, 2010
May 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (1)
To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
1 year
Study Arms (2)
hypertonic saline
EXPERIMENTALhypertonic saline (HS)
normal saline (NS)
PLACEBO COMPARATORnormal saline (NS)
Interventions
Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline
Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline
Eligibility Criteria
You may qualify if:
- infants less than 24 months of age with first episode of wheezing.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
zhengxiu luo, doctor
Chongqing Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 23, 2010
First Posted
May 11, 2010
Study Start
November 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
May 11, 2010
Record last verified: 2008-11