Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Magnesium Sulfate
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring magnesium, nebulization, asthma, sulfate, children, pediatric
Eligibility 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
Sites / Locations
- Hamad Medical CorporationRecruiting
- Pediatric Emergency CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
magnesium sulfate arm
placebo arm
Arm Description
magnesium sulfate with standard therapy
placebo with standard therapy
Outcomes
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?
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
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?
Full Information
NCT ID
NCT01584726
First Posted
April 17, 2012
Last Updated
January 27, 2014
Sponsor
Hamad Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01584726
Brief Title
Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma
Official Title
Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation: A Randomized, Double-Blind, Controlled Trial (RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
magnesium, nebulization, asthma, sulfate, children, pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
magnesium sulfate arm
Arm Type
Other
Arm Description
magnesium sulfate with standard therapy
Arm Title
placebo arm
Arm Type
No Intervention
Arm Description
placebo with standard therapy
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
single dose of magnesium sulfate nebulization
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
• Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease admission and readmission rate, compared to placebo
Description
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?
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Khalid Al Ansari, MD,FRCP,FAAP
Phone
97444396001
Ext
6006
Email
dkmaa@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Wessam Mouharam, MD
Phone
97444396022
Ext
6012
Email
wessam_mouharam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KHALID AL ANSARI, MD
Organizational Affiliation
SENIOR CONSULTANT-HEAD OF PEDIATRIC EMERGENCY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KHALID AL ANSARI, MD,FRCP,FAAP
Phone
+974 44396006
Ext
6001
Email
dkmaa@hotmail.com
First Name & Middle Initial & Last Name & Degree
WESSAM MOUHARAM, MD
Phone
+97444396022
Ext
6012
Email
wessam_mouharam@yahoo.com
First Name & Middle Initial & Last Name & Degree
Dr,KHALID AL ANSARI, MD,FRCP,FAAP
First Name & Middle Initial & Last Name & Degree
WESSAM MOUHARAM, MD
Facility Name
Pediatric Emergency Centre
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KHALID AL ANSARI, MD,FRCP,FAAP
Phone
97444396022
Ext
6006
Email
dkmaa@hotmail.com
First Name & Middle Initial & Last Name & Degree
WESSAM MOUHARAM, MD
Phone
9744396022
Ext
6012
Email
wessam_mouharam@yahoo.com
First Name & Middle Initial & Last Name & Degree
KHALID AL ANSARI, MD,FRCP,FAAP
First Name & Middle Initial & Last Name & Degree
WESSAM MOUHARAM, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
25652104
Citation
Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.
Results Reference
derived
Learn more about this trial
Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma
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