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Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hamad Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01584726
First received: April 17, 2012
Last updated: January 27, 2014
Last verified: January 2014
  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:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
    • 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

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
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: 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

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: January 27, 2014
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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Magnesium Sulfate
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 25, 2014