Intravenous Magnesium in Wheezy Bronchitis

Study Overview
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Brief Summary
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In infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always satisfactory. The purpose of this trial is to investigate the effectiveness of iv-magnesium in the treatment of moderate or severe bronchial obstruction associated with viral infection in small children. The study population will include the children attending the Pediatric Emergency Department of Oulu University Hospital because of respiratory infection and bronchial obstruction that is not relieved with conventional treatment. After written consent from the parents, the children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl. The primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours from the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time points and length of hospital stay. The sample size is 64 children at the age of 6 months to 4 years. If iv-magnesium is effective in relieving viral infection associated bronchial obstruction, that would be an important addition to the treatment of this common disease.

Detailed Description
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In infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always satisfactory. Intravenous infusion of magnesium sulfate has been proven to be efficacious and safe for the treatment of acute asthma attacks in adults and school-aged children. The purpose of this trial is to investigate the effectiveness of iv-magnesium in the treatment of moderate or severe bronchial obstruction associated with viral infection in small children. The study population will include the children attending the Pediatric Emergency Department of Oulu University Hospital because of respiratory infection and bronchial obstruction that is not relieved with conventional treatment. After written consent from the parents, the children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl. The primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours from the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time points and length of hospital stay. The sample size is 64 children at the age of 6 months to 4 years. If iv-magnesium is effective in relieving viral infection associated bronchial obstruction, that would be an important addition to the treatment of this common disease.

Official Title
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The Efficacy of Intravenous Magnesium in Acute Wheezy Bronchitis in Small Children - a Randomized, Controlled Study

Conditions
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Wheezy Bronchitis

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 0.5 - 4 years wheezy bronchitis RDAI > 6 after conventional treatment Exclusion Criteria: prematurity congenital heart disease immune deficiency

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium<br>i.v. magnesium infusion 40mg/kg in 20 min | Drug: Magnesium Sulfate<br>* i.v. magnesium 40mg/kg in 20 min<br>|
| Placebo Comparator: Placebo<br>i.v. 0.9 % NaCl | Drug: Placebo<br>* NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RDAI score |  | 6h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| saturation |  | 6h | 
| RDAI |  | 2h | 
| saturation |  | 2h | 
| length of hospital stay |  | length of hospital stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wheezy bronchitis, asthma, rhinovirus, magnesium