Wheezy Bronchitis Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03199976 -
Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
|
Phase 4 |