A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Hospitalization Days
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.
Detailed Description
Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.
The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Chronic respiratory or cardiovascular disease, respiratory failure.
Arms & Interventions
Hypertonic
Nebulized hypertonic saline (sodium chloride 3%) + albuterol
Intervention: Hypertonic saline (Drug)
Normal
Normal saline (sodium chloride 0.9%) + albuterol
Intervention: Normal saline (Drug)
Outcomes
Primary Outcomes
Hospitalization Days
Time Frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days
hospitalization days
Secondary Outcomes
- Length of Oxygen Use(Participants will be followed for the duration of hospitalization, an expected average of 4 days)