Trial | NCT00696540  Report issue

Title

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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    albuterol ...

  • Study Participants

    74
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.
Study Started
Jun 30
2008
Primary Completion
Sep 30
2008
Anticipated
Study Completion
Oct 31
2008
Anticipated
Last Update
Jun 12
2008
Estimate

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 names: 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 names: Albuterol diluted in normal saline

1 Experimental

Salbutamol is diluted in hypertonic (3%) saline.

2 Active Comparator

Salbutamol is diluted in normal (0.9%) saline.

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
No Results Posted