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Clinical Trials/NCT01238848
NCT01238848
Completed
Not Applicable

A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis

Hospital General de Niños Pedro de Elizalde1 site in 1 country82 target enrollmentDecember 2010

Overview

Phase
Not Applicable
Intervention
Hypertonic saline
Conditions
Bronchiolitis
Sponsor
Hospital General de Niños Pedro de Elizalde
Enrollment
82
Locations
1
Primary Endpoint
Hospitalization Days
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
May 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Normal

Normal saline (sodium chloride 0.9%) + albuterol

Intervention: Normal saline

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)

Study Sites (1)

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