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NCT01238848 Clinical Trial

Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

Bronchiolitis Clinical Trial

— Hypertonic  

Official title:
A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01238848
Other study ID # HGNPE-14-2010
Secondary ID
Status Completed
Phase N/A
First received November 9, 2010
Last updated July 16, 2012
Start date December 2010
Est. completion date May 2012

Study information
Verified date July 2012
Source Hospital General de Niños Pedro de Elizalde
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.

Description:

Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.

The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date May 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 2 Years
Eligibility Inclusion criteria:

- Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score = 5 points and oxygen saturation = 97%.

Exclusion Criteria:

- Chronic respiratory or cardiovascular disease, respiratory failure.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Hypertonic saline
3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
• Normal saline
3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Locations
Country Name City State
Argentina Hospital General de Niños Pedro de Elizalde Buenos Aires CF

Sponsors (1)
Lead Sponsor Collaborator
Hospital General de Niños Pedro de Elizalde

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16. — View Citation

Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2. Review. Update in: Cochrane Database Syst Rev. 2013;7:CD006458. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Hospitalization Days hospitalization days Participants will be followed for the duration of hospitalization, an expected average of 4 days No
Secondary Length of Oxygen Use Length of oxygen use (days) Participants will be followed for the duration of hospitalization, an expected average of 4 days No
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