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Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01584726
First received: April 17, 2012
Last updated: March 31, 2013
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to investigate the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency.


Condition Intervention
Asthma
 Drug: Magnesium Sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation: A Randomized, Double-Blind, Controlled Trial (RCT)

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • number of patients with moderate to severe asthma discharged at 24 hours. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of patients with moderate to severe asthma admitted to pediatric intensive care [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
magnesium sulfate arm
magnesium sulfate with standard therapy
 Drug: Magnesium Sulfate
single dose of magnesium sulfate nebulization
No Intervention: arm 1
placebo with standard therapy

Detailed Description:

the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency

follow asthma severity score and length of stay

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric asthma patients with moderate to severe exacerbation

Exclusion Criteria:

  • Known allergy to magnesium sulfate
  • History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
  • Use of oral steroid medication within 72 hours of presentation
  • Radiographic evidence of pneumonia at presentation
  • Administration of intravenous magnesium sulfate prior to study enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584726

Locations
Qatar
Hamad Medical Corporation
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation
  More Information

No publications provided

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01584726     History of Changes
Other Study ID Numbers: #12095/12
Study First Received: April 17, 2012
Last Updated: March 31, 2013
Health Authority: Qatar: Hamad Medical Corporation

Keywords provided by Hamad Medical Corporation:
magnesium
nebulization
asthma
 sulfate
children
pediatric

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
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
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 21, 2013