search
Back to results

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
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring magnesium, nebulization, asthma, sulfate, children, pediatric

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
April 17, 2012
Last Updated
January 27, 2014
Sponsor
Hamad Medical Corporation
search

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

We'll reach out to this number within 24 hrs