Hypertonic Saline for Outpatient Bronchiolitis

University Diego Portales

Status and phase: Unknown; Phase 2

Conditions: Bronchiolitis; Respiratory Distress

Treatments: Drug: Inhalation of salbutamol diluted in hypertonic saline; Drug: Inhalation of salbutamol diluted in normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00696540

UDP-CT1-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups

1

Experimental group

Description:

Salbutamol is diluted in hypertonic (3%) saline.

Treatment:

Drug: Inhalation of salbutamol diluted in hypertonic saline

2

Active Comparator group

Description:

Salbutamol is diluted in normal (0.9%) saline.

Treatment:

Drug: Inhalation of salbutamol diluted in normal saline