Intravenous Magnesium in Wheezy Bronchitis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Wheezy Bronchitis |
Drug: Magnesium Sulfate Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Efficacy of Intravenous Magnesium in Acute Wheezy Bronchitis in Small Children - a Randomized, Controlled Study |
- RDAI score [ Time Frame: 6h ] [ Designated as safety issue: No ]
- saturation [ Time Frame: 6h ] [ Designated as safety issue: No ]
- RDAI [ Time Frame: 2h ] [ Designated as safety issue: No ]
- saturation [ Time Frame: 2h ] [ Designated as safety issue: No ]
- length of hospital stay [ Time Frame: length of hospital stay ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Magnesium
i.v. magnesium 40mg/kg in 20 min
|
Drug: Magnesium Sulfate
i.v. magnesium 40mg/kg in 20 min
|
|
Placebo Comparator: Placebo
i.v. 0.9 % NaCl
|
Drug: Placebo
NaCl
|
Eligibility| Ages Eligible for Study: | 6 Months to 4 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 0.5 - 4 years
- wheezy bronchitis
- RDAI > 6 after conventional treatment
Exclusion Criteria:
- prematurity
- congenital heart disease
- immune deficiency
Contacts and Locations| Contact: Marjo Renko | +35883155132 | marjo.renko@oulu.fi |
| Contact: Marjo Renko | +3583155132 | marjo.renko@oulu.fi |
| Finland | |
| Department of Pediatrics, Oulu University Hospital | Recruiting |
| Oulu, Finland, 90230 | |
| Contact: Hannele Pruikkonen, MD +35883152011 hannele.pruikkonen@ppshp.fi | |
| Principal Investigator: Hannele Pruikkonen, MD | |
| Study Chair: | Marjo Renko, MD | University of Oulu, Department of Pediatrics |
More Information
No publications provided
| Responsible Party: | Marjo Renko, docent, University of Oulu |
| ClinicalTrials.gov Identifier: | NCT01383655 History of Changes |
| Other Study ID Numbers: | IVMg135/2010 |
| Study First Received: | June 6, 2011 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by University of Oulu:
|
wheezy bronchitis asthma rhinovirus magnesium |
Additional relevant MeSH terms:
|
Bronchitis Acute Disease Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Disease Attributes Pathologic Processes Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Magnesium Sulfate |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013