Bronchiolitis, Respiratory Distress
Conditions
Keywords
Bronchiolitis, respiratory distress, hypertonic saline
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.
Interventions
DRUGInhalation 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.
DRUGInhalation 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.
Sponsors
Clínica Vespucio, Santiago, Chile
University Diego Portales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations | 1 hour |
Secondary
| Measure | Time frame |
|---|---|
| Change in the respiratory distress score (Tal) between the basal score and the first nebulization | 15 to 20 minutes |
| Change in the respiratory distress score (Tal) between the basal score and the second nebulization | 15 to 20 minutes after the first nebulization |
| Change in pulse oxymetry reading between the basal score and after each of the three nebulizations | 1 hour |
| Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization | 1 hour |
Countries
Chile
Contacts
Primary ContactIrmeli Roine, MD, PhD
Backup ContactRicardo Mercado, MD
Outcome results
None listed