Intravenous Magnesium in Wheezy Bronchitis
The Efficacy of Intravenous Magnesium in Acute Wheezy Bronchitis in Small Children - a Randomized, Controlled Study
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 6, 2011
CompletedFirst Posted
Study publicly available on registry
June 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 21, 2016
January 1, 2016
4.8 years
June 6, 2011
January 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
RDAI score
6h
Secondary Outcomes (4)
saturation
6h
RDAI
2h
saturation
2h
length of hospital stay
length of hospital stay
Study Arms (2)
Magnesium
EXPERIMENTALi.v. magnesium infusion 40mg/kg in 20 min
Placebo
PLACEBO COMPARATORi.v. 0.9 % NaCl
Interventions
Eligibility Criteria
You may qualify if:
- age 0.5 - 4 years
- wheezy bronchitis
- RDAI \> 6 after conventional treatment
You may not qualify if:
- prematurity
- congenital heart disease
- immune deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics, Oulu University Hospital
Oulu, Oulu, 90230, Finland
Related Publications (1)
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.
PMID: 29437941DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marjo Renko, MD
University of Oulu, Department of Pediatrics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- docent
Study Record Dates
First Submitted
June 6, 2011
First Posted
June 28, 2011
Study Start
March 1, 2011
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 21, 2016
Record last verified: 2016-01