Clinical trial NCT02045238: Inhaled Hypertonic Saline Use in the Emergency Department to Treat Acute Viral Bronchiolitis
Official title: Study of the Effect of Inhaled 3% Hypertonic Saline Compared With Normal Saline (0,9%) for the Treatment of Acute Viral Bronchiolitis in a Short Stay Ward
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis
Keywords: Bronchiolitis
Therapeutics
Saline Solution, Hypertonic
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 32
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute viral bronchiolitis is an extremely common childhood disease, responsible for approximately 17% of childhood admissions to hospital per year, with an annually cost that reaches U$ 500 million.

Despite being a well known disease among pediatricians, there are few, if any, effective treatment options apart from oxygen supplementation and adequate hydration.

The purpose of this study is to determine wether nebulized hypertonic saline (3%) is more effective than normal saline (0,9%) when used in repeated doses during the first 24 hours of in-hospital treatment.

Detailed description: Acute viral bronchiolitis is a lower airway infection, caused manly by Respiratory Syncytial Virus. Near 1% of children up to 2 years of age get it with sufficient severity to warrant hospital admission, with an annual cost of about U$ 500 million in the US, superior, for instance, than cystic fibrosis annual cost.

Despite the physiopathology and clinical course being well known among pediatricians, few therapeutical options other than adequate hydration and oxygen supplementation have proven to be effective Corticosteroids are not effective and bronchodilators are controversial, and treatment is still mostly empiric and lacking evidence.

In the last few years, there has been a growing interest in the use of nebulized hypertonic saline (HS) as a promising approach. The rational is that HS would help reducing edema and mucus viscosity, enhancing its rheologic properties. Recent studies suggest that HS could reduce up to 1 day (25%) of time until discharge in admitted patients. In the Emergency Department, HS was not superior to other forms of treatment, but these studies lack power and similarities to draw further conclusions. Also, time of treatment and ideal interval between doses are not known as yet.

To our knowledge, few if any studies have assessed patients with an intermediary (up to 24h) time of stay, namely a short stay ward attached to an emergency department. Thus, we have endeavoured to determine if repeated doses of nebulized HS are superior to nebulized normal saline (NS) during the first 24 hour of treatment, when considered: rate of admission, time until discharge, time until attain discharge criteria, and rate of readmission after discharge.

Furthermore, most studies use HS associated to a bronchodilator, because of a theoretical possibility that HS alone could induce bronchoconstriction and worsen respiratory symptoms. However, recent studies have shown that HS use without bronchodilators have not caused any worsening of symptoms in bronchiolitis patients. Therefore, we propose to study the effect of HS alone, without the adding of bronchodilators, which would minimize bias in the treatment group.

Eligibility criteria: Inclusion Criteria:

* Age \< 12 months
* Clinical diagnosis of bronchiolitis (viral respiratory disease and wheezing)
* First episode of wheezing in life
* Moderate respiratory distress, defined as 2 of the following: Sat \<93%, respiratory rate \>60 and/or RDAI score \>4

Exclusion Criteria:

* Previous episodes of wheezing in history
* Use of bronchodilators, corticosteroids or antibiotics in the 24 hours prior to admission or at any time during treatment.
* Other clinical conditions such as: prematurity, bronchopulmonary dysplasia, cystic fibrosis, cardiac disease or immunodeficiencies.
* detection of alveolar infiltrates suggestive of pneumonia in radiologic examination
* respiratory impairment requiring mechanical ventilation on arrival to hospital.

Primary outcomes:
measure: Rate of Admission
timeFrame: 24 hours
measure: Time to Attain Discharge Criteria
timeFrame: 24 hours
Secondary outcomes:
measure: Time to Discharge
timeFrame: 24 hours
measure: Rate of Readmission After Discharge
timeFrame: 5 days
measure: Incidence of Adverse Effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University Hospital of Sao Paulo University
state: SP
Study officials:
affiliation: Sao Paulo University
name: Mateus D Leme, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anil AB, Anil M, Saglam AB, Cetin N, Bal A, Aksu N. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3% saline in mild bronchiolitis. Pediatr Pulmonol. 2010 Jan;45(1):41-7. doi: 10.1002/ppul.21108.
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.
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citation: Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD006458. doi: 10.1002/14651858.CD006458.pub3.
citation: Principi T, Komar L. A critical review of "a randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department.". J Popul Ther Clin Pharmacol. 2011;18(2):e273-4. Epub 2011 May 16. No abstract available.
citation: Jacobs JD, Foster M, Wan J, Pershad J. 7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial. Pediatrics. 2014 Jan;133(1):e8-13. doi: 10.1542/peds.2013-1646. Epub 2013 Dec 16.
citation: Mandelberg A, Amirav I. Hypertonic saline or high volume normal saline for viral bronchiolitis: mechanisms and rationale. Pediatr Pulmonol. 2010 Jan;45(1):36-40. doi: 10.1002/ppul.21185. No abstract available.
citation: Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.