Last updated on February 2018

Magnesium Nebulization Utilization in Management of Pediatric Asthma


Brief description of study

Acute asthma is the most common cause of pediatric hospitalizations. While the investigators know that repeat inhalations of 2 agonists and ipratropium with early oral steroids substantially reduce hospitalizations, many children are resistant to this standard initial therapy. About a third of children remaining in moderate to severe distress after standard therapy are admitted to hospital and comprise 84% of pediatric acute asthma hospitalizations. Finding safe, non-invasive, and effective strategies to treat children resistant to standard therapy would substantially decrease hospitalizations resulting in considerable health care savings and reduction of the psycho-social burden of the disease. While studies of magnesium sulfate (Mg) given intravenously (IV) suggest that this agent can reduce hospitalizations in both adults and children resistant to standard initial therapy Nebulization is an alternate route for administering Mg. This route has the advantage of being non-invasive and is likely much safer due to lower systemic delivery. Direct delivery via nebulization allows higher Mg concentrations at the target site, the lower airways, with a smaller total drug dose. The investigators propose to conduct a properly designed study to clarify the role of nebulized Mg.

Detailed Study Description

The investigators plan the following specific aims:

  1. Primary Objective: To examine if in children with acute asthma remaining in moderate to severe respiratory distress despite maximized initial bronchodilator and steroid therapy there is a reduction in hospitalization rate from the ED in those who receive nebulized Mg with salbutamol versus those receiving salbutamol only.
     Hypothesis: The investigators hypothesize that the children with Pediatric Respiratory
     Assessment Measure (PRAM)  5 points after optimized initial inhaled bronchodilator and
     oral steroid therapies who are given nebulized Mg in addition to nebulized salbutamol
     will have significantly lower hospitalization rate within 24 hours of starting the study
     compared to those given salbutamol only.

2. To compare a difference in the changes in the validated Pediatric Respiratory Assessment

     Measure (PRAM), respiratory rate, oxygen saturation and blood pressure from
     randomization baseline to 240 minutes in the two groups

3. To determine if there is a significant association between the difference in the primary

     outcome between the groups and the patient's age, gender, baseline PRAM score, personal
     history of atopy and "viral-induced wheeze" phenotype.

Hypothesis(es) to be Tested In this randomized, double-blind seven-centre trial, the investigators hypothesize that children with acute asthma with a Pediatric Respiratory Assessment Measure (PRAM) of 5 points after optimized initial inhaled bronchodilator and oral steroid therapies who are given nebulized Mg in addition to nebulized salbutamol will have at least a 10% lower hospitalization rate within 24 hours of starting the study as compared to those given salbutamol only.

Clinical Study Identifier: NCT01429415

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Recruitment Status: Open


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