Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Drug: Hypertonic saline; Drug: Normal saline

• Registration Number: NCT01238848
• Lead Sponsor: Hospital General de Niños Pedro de Elizalde

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 Timeline

• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Study Start: 2010-12
• Primary Completion: 2011-10
• Study Completion: 2012-05
• Status Verified: 2012-07
• Results First Submitted: 2012-07-16
• Results First Submitted QC: 2012-07-16
• Results First Posted: 2012-08-17
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

• Chronic respiratory or cardiovascular disease, respiratory failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic	Hypertonic saline	Nebulized hypertonic saline (sodium chloride 3%) + albuterol
Normal	Normal saline	Normal saline (sodium chloride 0.9%) + albuterol

Primary Outcome Measures

Name	Time	Method
Hospitalization Days	Participants will be followed for the duration of hospitalization, an expected average of 4 days	hospitalization days

Secondary Outcome Measures

Name	Time	Method
Length of Oxygen Use	Participants will be followed for the duration of hospitalization, an expected average of 4 days	Length of oxygen use (days)

Trial Locations

Locations (1)

Hospital General de Niños Pedro de Elizalde; 🇦🇷 Buenos Aires, CF, Argentina