Hypertonic Saline for Outpatient Bronchiolitis
Information source: University Diego Portales
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchiolitis; Respiratory Distress
Intervention: Inhalation of salbutamol diluted in hypertonic saline (Drug); Inhalation of salbutamol diluted in normal saline (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Diego Portales Official(s) and/or principal investigator(s): Irmeli Roine, MD, PhD, Principal Investigator, Affiliation: University Diego Portales Ricardo Mercado, MD, Study Director, Affiliation: Clinica Vespucio, Santiago, Chile
Overall contact: Irmeli Roine, MD, PhD, Phone: +56-2-6762916, Email: irmeli.roine@prof.udp.cl
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations
Secondary outcome: Change in the respiratory distress score (Tal) between the basal score and the first nebulizationChange in the respiratory distress score (Tal) between the basal score and the second nebulization Change in pulse oxymetry reading between the basal score and after each of the three nebulizations Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization
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
Minimum age: 1 Month.
Maximum age: 24 Months.
Gender(s): Both.
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
Locations and Contacts
Irmeli Roine, MD, PhD, Phone: +56-2-6762916, Email: irmeli.roine@prof.udp.cl
ClĂnica Vespucio, Santiago 00300, Chile; Recruiting Ricardo Mercado, MD, Phone: +56-2-8206500, Email: rmercado@ssmso.cl Patricio Olivares, MD, Phone: +56-2-8206500, Email: patovares@gmail.com
Additional Information
Related publications: 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. 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.
Starting date: June 2008
Last updated: June 9, 2008
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