Study Results
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Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2011-03-31
2016-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Magnesium
i.v. magnesium infusion 40mg/kg in 20 min
Magnesium Sulfate
i.v. magnesium 40mg/kg in 20 min
Placebo
i.v. 0.9 % NaCl
Placebo
NaCl
Interventions
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Magnesium Sulfate
i.v. magnesium 40mg/kg in 20 min
Placebo
NaCl
Eligibility Criteria
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Inclusion Criteria
* wheezy bronchitis
* RDAI \> 6 after conventional treatment
Exclusion Criteria
* congenital heart disease
* immune deficiency
6 Months
4 Years
ALL
No
Sponsors
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University of Oulu
OTHER
Responsible Party
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Marjo Renko
docent
Principal Investigators
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Marjo Renko, MD
Role: STUDY_CHAIR
University of Oulu, Department of Pediatrics
Locations
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Department of Pediatrics, Oulu University Hospital
Oulu, Oulu, Finland
Countries
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References
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Pruikkonen H, Tapiainen T, Kallio M, Dunder T, Pokka T, Uhari M, Renko M. Intravenous magnesium sulfate for acute wheezing in young children: a randomised double-blind trial. Eur Respir J. 2018 Feb 7;51(2):1701579. doi: 10.1183/13993003.01579-2017. Print 2018 Feb.
Other Identifiers
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IVMg135/2010
Identifier Type: -
Identifier Source: org_study_id
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