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Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis (Hypertonic)

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Hypertonic saline
Normal saline
Sponsored by
Hospital General de Niños Pedro de Elizalde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Hypertonic, Saline, Bronchiolitis, Efficacy

Eligibility Criteria

1 Month - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Exclusion Criteria:

  • Chronic respiratory or cardiovascular disease, respiratory failure.

Sites / Locations

  • Hospital General de Niños Pedro de Elizalde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypertonic

Normal

Arm Description

Nebulized hypertonic saline (sodium chloride 3%) + albuterol

Normal saline (sodium chloride 0.9%) + albuterol

Outcomes

Primary Outcome Measures

Hospitalization Days
hospitalization days

Secondary Outcome Measures

Length of Oxygen Use
Length of oxygen use (days)

Full Information

First Posted
November 9, 2010
Last Updated
December 20, 2016
Sponsor
Hospital General de Niños Pedro de Elizalde
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1. Study Identification

Unique Protocol Identification Number
NCT01238848
Brief Title
Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis
Acronym
Hypertonic
Official Title
A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General de Niños Pedro de Elizalde

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Hypertonic, Saline, Bronchiolitis, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertonic
Arm Type
Experimental
Arm Description
Nebulized hypertonic saline (sodium chloride 3%) + albuterol
Arm Title
Normal
Arm Type
Active Comparator
Arm Description
Normal saline (sodium chloride 0.9%) + albuterol
Intervention Type
Drug
Intervention Name(s)
Hypertonic saline
Other Intervention Name(s)
ClNa 3% (sodium chloride 3%)
Intervention Description
3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
ClNa 0.9% (sodium chloride 0.9%)
Intervention Description
3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
Primary Outcome Measure Information:
Title
Hospitalization Days
Description
hospitalization days
Time Frame
Participants will be followed for the duration of hospitalization, an expected average of 4 days
Secondary Outcome Measure Information:
Title
Length of Oxygen Use
Description
Length of oxygen use (days)
Time Frame
Participants will be followed for the duration of hospitalization, an expected average of 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%. Exclusion Criteria: Chronic respiratory or cardiovascular disease, respiratory failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria I Espelt, MD
Organizational Affiliation
Hospital General de Niños Pedro de Elizalde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Niños Pedro de Elizalde
City
Buenos Aires
State/Province
CF
ZIP/Postal Code
C1270AAN
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
18843717
Citation
Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.
Results Reference
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PubMed Identifier
20713480
Citation
Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
Results Reference
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Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

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