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Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Hamad Medical Corporation.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01584726
First Posted: April 25, 2012
Last Update Posted: January 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hamad Medical Corporation
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma significantly reduce the time to clinical readiness for discharge? [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • • Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease admission and readmission rate, compared to placebo [ Time Frame: 36 months ]
    • Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease PICU admission rate, compared to placebo?
    • Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma improve change in asthma severity score at 4, 8, 12 hours, compared to placebo?
    • Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease return rate to emergency services, compared to placebo?
    • Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease rate of infirmray admission in follow up, compared to placebo?


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: placebo arm
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584726


Contacts
Contact: Dr. Khalid Al Ansari, MD,FRCP,FAAP 97444396001 ext 6006 dkmaa@hotmail.com
Contact: Dr. Wessam Mouharam, MD 97444396022 ext 6012 wessam_mouharam@yahoo.com

Locations
Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar, 3050
Contact: KHALID AL ANSARI, MD,FRCP,FAAP    +974 44396006 ext 6001    dkmaa@hotmail.com   
Contact: WESSAM MOUHARAM, MD    +97444396022 ext 6012    wessam_mouharam@yahoo.com   
Principal Investigator: Dr,KHALID AL ANSARI, MD,FRCP,FAAP         
Sub-Investigator: WESSAM MOUHARAM, MD         
Pediatric Emergency Centre Recruiting
Doha, Qatar, 3050
Contact: KHALID AL ANSARI, MD,FRCP,FAAP    97444396022 ext 6006    dkmaa@hotmail.com   
Contact: WESSAM MOUHARAM, MD    9744396022 ext 6012    wessam_mouharam@yahoo.com   
Principal Investigator: KHALID AL ANSARI, MD,FRCP,FAAP         
Sub-Investigator: WESSAM MOUHARAM, MD         
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Principal Investigator: KHALID AL ANSARI, MD SENIOR CONSULTANT-HEAD OF PEDIATRIC EMERGENCY
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01584726     History of Changes
Other Study ID Numbers: #12095/12
First Submitted: April 17, 2012
First Posted: April 25, 2012
Last Update Posted: January 28, 2014
Last Verified: January 2014

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
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents