Intravenous Magnesium in Wheezy Bronchitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
Marjo Renko, University of Oulu
ClinicalTrials.gov Identifier:
NCT01383655
First received: June 6, 2011
Last updated: May 8, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • RDAI score [ Time Frame: 6h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 2015 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383655

Contacts
Contact: Marjo Renko +35883155132 marjo.renko@oulu.fi
Contact: Marjo Renko +3583155132 marjo.renko@oulu.fi

Locations
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         
Sponsors and Collaborators
University of Oulu
Investigators
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: May 8, 2014
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 August 28, 2014