Intravenous Magnesium in Wheezy Bronchitis
Primary Purpose
Wheezy Bronchitis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Magnesium Sulfate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Wheezy Bronchitis focused on measuring wheezy bronchitis, asthma, rhinovirus, magnesium
Eligibility Criteria
Inclusion Criteria:
- age 0.5 - 4 years
- wheezy bronchitis
- RDAI > 6 after conventional treatment
Exclusion Criteria:
- prematurity
- congenital heart disease
- immune deficiency
Sites / Locations
- Department of Pediatrics, Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium
Placebo
Arm Description
i.v. magnesium infusion 40mg/kg in 20 min
i.v. 0.9 % NaCl
Outcomes
Primary Outcome Measures
RDAI score
Secondary Outcome Measures
saturation
RDAI
saturation
length of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01383655
Brief Title
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheezy Bronchitis
Keywords
wheezy bronchitis, asthma, rhinovirus, magnesium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium
Arm Type
Experimental
Arm Description
i.v. magnesium infusion 40mg/kg in 20 min
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
i.v. 0.9 % NaCl
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
i.v. magnesium 40mg/kg in 20 min
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
NaCl
Primary Outcome Measure Information:
Title
RDAI score
Time Frame
6h
Secondary Outcome Measure Information:
Title
saturation
Time Frame
6h
Title
RDAI
Time Frame
2h
Title
saturation
Time Frame
2h
Title
length of hospital stay
Time Frame
length of hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 0.5 - 4 years
wheezy bronchitis
RDAI > 6 after conventional treatment
Exclusion Criteria:
prematurity
congenital heart disease
immune deficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjo Renko, MD
Organizational Affiliation
University of Oulu, Department of Pediatrics
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pediatrics, Oulu University Hospital
City
Oulu
ZIP/Postal Code
90230
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
29437941
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.
Results Reference
derived
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Intravenous Magnesium in Wheezy Bronchitis
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