Clinical trial NCT00696540: Hypertonic Saline for Outpatient Bronchiolitis
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bronchiolitis
Respiratory Distress
Keywords: Bronchiolitis, respiratory distress, hypertonic saline
Lead sponsor: University Diego Portales
Sponsor class: OTHER
Collaborators: name: Clínica Vespucio, Santiago, Chile
First posted: 2008-06-12
Enrollment: 74
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations
timeFrame: 1 hour
Secondary outcomes:
measure: Change in the respiratory distress score (Tal) between the basal score and the first nebulization
timeFrame: 15 to 20 minutes
measure: Change in the respiratory distress score (Tal) between the basal score and the second nebulization
timeFrame: 15 to 20 minutes after the first nebulization
measure: Change in pulse oxymetry reading between the basal score and after each of the three nebulizations
timeFrame: 1 hour
measure: Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization
timeFrame: 1 hour
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clínica Vespucio
Study officials:
affiliation: University Diego Portales
name: Irmeli Roine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Vespucio, Santiago, Chile
name: Ricardo Mercado, MD
role: STUDY_DIRECTOR
References:
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.
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.