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Wheezy Bronchitis | Intravenous Magnesium in Wheezy Bronchitis

Wheezy Bronchitis research study

What is the primary objective of this 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.

Who is eligible to participate?

Inclusion Criteria: - age 0.5 - 4 years - wheezy bronchitis - RDAI > 6 after conventional treatment Exclusion Criteria: - prematurity - congenital heart disease - immune deficiency

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Wheezy Bronchitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Magnesium Sulfatei.v. magnesium 40mg/kg in 20 min

Drug:PlaceboNaCl

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Magnesiumi.v. magnesium infusion 40mg/kg in 20 min

Placeboi.v. 0.9 % NaCl

Study Status

Completed

Start Date: March 2011

Completed Date: January 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: RDAI score

Secondary Outcome: saturation

Study sponsors, principal investigator, and references

Principal Investigator: Marjo Renko, MD

Lead Sponsor: University of Oulu

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01383655

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