A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 135
- Primary Endpoint
- To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Month to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
hypertonic saline
hypertonic saline (HS)
Intervention: 3% hypertonic saline (Drug)
normal saline (NS)
normal saline (NS)
Intervention: normal saline (Drug)
Outcomes
Primary Outcomes
To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
Time Frame: 1 year
Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS.
Secondary Outcomes
- To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis(1 year)