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Hypertonic Saline for Outpatient Bronchiolitis (Hypertonic)

Primary Purpose

Bronchiolitis, Respiratory Distress

Status
Unknown status
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Inhalation of salbutamol diluted in hypertonic saline
Inhalation of salbutamol diluted in normal saline
Sponsored by
University Diego Portales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, respiratory distress, hypertonic saline

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 1 to 24 months
  2. Mild to moderate respiratory distress (Tal score below 9)
  3. Up to 5 days of respiratory symptoms, including today
  4. Expiratory wheezing heard on chest auscultation
  5. Indication of salbutamol nebulization treatment by attending physician

Exclusion Criteria:

  1. Two prior episodes of wheezing
  2. Premature birth (below 38 weeks), if below 6 months of age
  3. Lobar pneumonia
  4. Body temperature above 38 degree Celsius
  5. Use of salbutamol during the previous 6 hours
  6. Pulse oxymetry reading below 90%
  7. Congenital heart disease
  8. Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia
  9. Other chronic or genetic condition or disease

Sites / Locations

  • Clínica VespucioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Salbutamol is diluted in hypertonic (3%) saline.

Salbutamol is diluted in normal (0.9%) saline.

Outcomes

Primary Outcome Measures

Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations

Secondary Outcome Measures

Change in the respiratory distress score (Tal) between the basal score and the first nebulization
Change in the respiratory distress score (Tal) between the basal score and the second nebulization
Change in pulse oxymetry reading between the basal score and after each of the three nebulizations
Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization

Full Information

First Posted
June 9, 2008
Last Updated
June 9, 2008
Sponsor
University Diego Portales
Collaborators
Clínica Vespucio, Santiago, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT00696540
Brief Title
Hypertonic Saline for Outpatient Bronchiolitis
Acronym
Hypertonic
Official Title
Safety and Efficacy of Hypertonic Vrs. Normal Saline as Diluent of Salbutamol to Reduce Respiratory Distress in Outpatients With the Clinical Diagnosis of Bronchiolitis During the RSV Epidemic.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Diego Portales
Collaborators
Clínica Vespucio, Santiago, Chile

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We will study if small children who become ill with respiratory distress during the RSV epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%), instead of normal (0.9%) saline.
Detailed Description
In Santiago, Chile, a near collapse of health services is a notorious feature of every winter when vast numbers of small children line for attention because of respiratory distress caused by a probable RSV infection. Our study will examine if nebulized salbutamol diluted in hypertonic (3%), instead of normal (0.9%) saline, provides better relief in outpatients. If hypertonic saline proves safe and effective, the patients could be better managed and the pressure for attention diminished at a low cost, by a simple change in the saline ampule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Respiratory Distress
Keywords
Bronchiolitis, respiratory distress, hypertonic saline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Salbutamol is diluted in hypertonic (3%) saline.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Salbutamol is diluted in normal (0.9%) saline.
Intervention Type
Drug
Intervention Name(s)
Inhalation of salbutamol diluted in hypertonic saline
Other Intervention Name(s)
Albuterol diluted in hypertonic saline
Intervention Description
The first of 3 nebulizations of 0.5 mg of Salbutamol is diluted in 3.5 ml of hypertonic (3%) saline. The second and the third are diluted in normal (0.9%) saline.
Intervention Type
Drug
Intervention Name(s)
Inhalation of salbutamol diluted in normal saline
Other Intervention Name(s)
Albuterol diluted in normal saline
Intervention Description
The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline.
Primary Outcome Measure Information:
Title
Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Change in the respiratory distress score (Tal) between the basal score and the first nebulization
Time Frame
15 to 20 minutes
Title
Change in the respiratory distress score (Tal) between the basal score and the second nebulization
Time Frame
15 to 20 minutes after the first nebulization
Title
Change in pulse oxymetry reading between the basal score and after each of the three nebulizations
Time Frame
1 hour
Title
Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 1 to 24 months Mild to moderate respiratory distress (Tal score below 9) Up to 5 days of respiratory symptoms, including today Expiratory wheezing heard on chest auscultation Indication of salbutamol nebulization treatment by attending physician Exclusion Criteria: Two prior episodes of wheezing Premature birth (below 38 weeks), if below 6 months of age Lobar pneumonia Body temperature above 38 degree Celsius Use of salbutamol during the previous 6 hours Pulse oxymetry reading below 90% Congenital heart disease Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia Other chronic or genetic condition or disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irmeli Roine, MD, PhD
Phone
+56-2-6762916
Email
irmeli.roine@prof.udp.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo Mercado, MD
Phone
+56-9-3320792
Email
rmercado@ssmso.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irmeli Roine, MD, PhD
Organizational Affiliation
University Diego Portales
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ricardo Mercado, MD
Organizational Affiliation
Clinica Vespucio, Santiago, Chile
Official's Role
Study Director
Facility Information:
Facility Name
Clínica Vespucio
City
Santiago
ZIP/Postal Code
00300
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Mercado, MD
Phone
+56-2-8206500
Email
rmercado@ssmso.cl
First Name & Middle Initial & Last Name & Degree
Patricio Olivares, MD
Phone
+56-2-8206500
Email
patovares@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
12475841
Citation
Sarrell EM, Tal G, Witzling M, Someck E, Houri S, Cohen HA, Mandelberg A. Nebulized 3% hypertonic saline solution treatment in ambulatory children with viral bronchiolitis decreases symptoms. Chest. 2002 Dec;122(6):2015-20. doi: 10.1378/chest.122.6.2015.
Results Reference
background
PubMed Identifier
12576370
Citation
Mandelberg A, Tal G, Witzling M, Someck E, Houri S, Balin A, Priel IE. Nebulized 3% hypertonic saline solution treatment in hospitalized infants with viral bronchiolitis. Chest. 2003 Feb;123(2):481-7. doi: 10.1378/chest.123.2.481.
Results Reference
background

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Hypertonic Saline for Outpatient Bronchiolitis

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