Hypertonic Saline for Outpatient Bronchiolitis

Bronchiolitis Clinical Trial

— Hypertonic  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00696540
• Other study ID #: UDP-CT1-08
• Status: Recruiting
• Phase: Phase 2
• First received: June 9, 2008
• Last updated: June 9, 2008
• Start date: June 2008
• Est. completion date: October 2008

Study information

• Verified date: June 2008
• Source: University Diego Portales
• Contact: Irmeli Roine, MD, PhD
• Phone: +56-2-6762916
• Email: irmeli.roine[@]prof.udp.cl
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Respiratory Distress

Intervention

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.
• 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.

Locations

Country	Name	City	State
Chile	Clínica Vespucio	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
University Diego Portales	Clínica Vespucio, Santiago, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations		1 hour	No
Secondary	Change in the respiratory distress score (Tal) between the basal score and the first nebulization		15 to 20 minutes	No
Secondary	Change in the respiratory distress score (Tal) between the basal score and the second nebulization		15 to 20 minutes after the first nebulization	No
Secondary	Change in pulse oxymetry reading between the basal score and after each of the three nebulizations		1 hour	No
Secondary	Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization		1 hour	Yes