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Intravenous Magnesium in Wheezy Bronchitis

U

University of Oulu

Status

Completed

Conditions

Wheezy Bronchitis

Treatments

Drug: Magnesium Sulfate
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01383655
IVMg135/2010

Details and patient eligibility

About

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.

Full description

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.

Enrollment

61 patients

Sex

All

Ages

6 months to 4 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • prematurity
  • congenital heart disease
  • immune deficiency

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

61 participants in 2 patient groups, including a placebo group

Magnesium
Experimental group
Description:
i.v. magnesium infusion 40mg/kg in 20 min
Treatment:
Drug: Magnesium Sulfate
Placebo
Placebo Comparator group
Description:
i.v. 0.9 % NaCl
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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