Clinical Trial: Intravenous Magnesium in Wheezy Bronchitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Efficacy of Intravenous Magnesium in Acute Wheezy Bronchitis in Small Children - a Randomized, Controlled Study
Brief Summary:
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 Summary:
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.
Sponsor: University of Oulu
Current Primary Outcome: RDAI score [ Time Frame: 6h ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- saturation [ Time Frame: 6h ]
- RDAI [ Time Frame: 2h ]
- saturation [ Time Frame: 2h ]
- length of hospital stay [ Time Frame: length of hospital stay ]
Original Secondary Outcome:
- saturation [ Time Frame: 6h ]
- RDAI [ Time Frame: 2h ]
- saturation [ Time Frame: 2h ]
- length of hospital stay
Information By: University of Oulu
Dates:
Date Received: June 6, 2011
Date Started: March 2011
Date Completion:
Last Updated: January 20, 2016
Last Verified: January 2016
