ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Magnesium in Wheezy Bronchitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01383655
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Marjo Renko, University of Oulu

June 6, 2011
June 28, 2011
January 21, 2016
March 2011
January 2016   (Final data collection date for primary outcome measure)
RDAI score [ Time Frame: 6h ]
Same as current
Complete list of historical versions of study NCT01383655 on ClinicalTrials.gov Archive Site
  • saturation [ Time Frame: 6h ]
  • RDAI [ Time Frame: 2h ]
  • saturation [ Time Frame: 2h ]
  • length of hospital stay [ Time Frame: length of hospital stay ]
  • saturation [ Time Frame: 6h ]
  • RDAI [ Time Frame: 2h ]
  • saturation [ Time Frame: 2h ]
  • length of hospital stay
Not Provided
Not Provided
 
Intravenous Magnesium in Wheezy Bronchitis
The Efficacy of Intravenous Magnesium in Acute Wheezy Bronchitis in Small Children - a Randomized, Controlled Study

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Wheezy Bronchitis
  • Drug: Magnesium Sulfate
    i.v. magnesium 40mg/kg in 20 min
  • Drug: Placebo
    NaCl
  • Experimental: Magnesium
    i.v. magnesium infusion 40mg/kg in 20 min
    Intervention: Drug: Magnesium Sulfate
  • Placebo Comparator: Placebo
    i.v. 0.9 % NaCl
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
64
January 2016
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 0.5 - 4 years
  • wheezy bronchitis
  • RDAI > 6 after conventional treatment

Exclusion Criteria:

  • prematurity
  • congenital heart disease
  • immune deficiency
Sexes Eligible for Study: All
6 Months to 4 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01383655
IVMg135/2010
No
Not Provided
Not Provided
Marjo Renko, University of Oulu
University of Oulu
Not Provided
Study Chair: Marjo Renko, MD University of Oulu, Department of Pediatrics
University of Oulu
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP