Clinical trial NCT01383655: Intravenous Magnesium in Wheezy Bronchitis
Official title: The Efficacy of Intravenous Magnesium in Acute Wheezy Bronchitis in Small Children - a Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wheezy Bronchitis
Keywords: wheezy bronchitis
asthma
rhinovirus
magnesium
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 61
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* prematurity
* congenital heart disease
* immune deficiency

Primary outcomes:
measure: RDAI score
timeFrame: 6h
Secondary outcomes:
measure: saturation
timeFrame: 6h
measure: RDAI
timeFrame: 2h
measure: saturation
timeFrame: 2h
measure: length of hospital stay
timeFrame: length of hospital stay
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Department of Pediatrics, Oulu University Hospital
Study officials:
affiliation: University of Oulu, Department of Pediatrics
name: Marjo Renko, MD
role: STUDY_CHAIR
References:
citation: 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.