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Hypertonic Saline for Outpatient Bronchiolitis (Hypertonic)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University Diego Portales.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696540
First Posted: June 12, 2008
Last Update Posted: June 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Clínica Vespucio, Santiago, Chile
Information provided by:
University Diego Portales
June 9, 2008
June 12, 2008
June 12, 2008
June 2008
September 2008   (Final data collection date for primary outcome measure)
Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations [ Time Frame: 1 hour ]
Same as current
No Changes Posted
  • Change in the respiratory distress score (Tal) between the basal score and the first nebulization [ Time Frame: 15 to 20 minutes ]
  • 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 ]
  • Change in pulse oxymetry reading between the basal score and after each of the three nebulizations [ Time Frame: 1 hour ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
Hypertonic Saline for Outpatient Bronchiolitis
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.
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bronchiolitis
  • Respiratory Distress
  • Drug: Inhalation of salbutamol diluted in hypertonic saline
    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.
    Other Name: Albuterol diluted in hypertonic saline
  • Drug: Inhalation of salbutamol diluted in normal saline
    The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline.
    Other Name: Albuterol diluted in normal saline
  • Experimental: 1
    Salbutamol is diluted in hypertonic (3%) saline.
    Intervention: Drug: Inhalation of salbutamol diluted in hypertonic saline
  • Active Comparator: 2
    Salbutamol is diluted in normal (0.9%) saline.
    Intervention: Drug: Inhalation of salbutamol diluted in normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
74
October 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
1 Month to 24 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
 
NCT00696540
UDP-CT1-08
Yes
Not Provided
Not Provided
Irmeli Roine, Facultad de Ciencias de la Salud, Universidad Diego Portales, Santiago. Chile
University Diego Portales
Clínica Vespucio, Santiago, Chile
Principal Investigator: Irmeli Roine, MD, PhD University Diego Portales
Study Director: Ricardo Mercado, MD Clinica Vespucio, Santiago, Chile
University Diego Portales
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP