Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma

January 27, 2014 updated by: Hamad Medical Corporation

Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation: A Randomized, Double-Blind, Controlled Trial (RCT)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Khalid Al Ansari, MD,FRCP,FAAP
  • Phone Number: 6006 97444396001
  • Email: dkmaa@hotmail.com

Study Contact Backup

Study Locations

  • Qatar
      • Doha, Qatar, 3050
        • Recruiting
        • Hamad Medical Corporation
        • Contact:
          • KHALID AL ANSARI, MD,FRCP,FAAP
          • Phone Number: 6001 +974 44396006
          • Email: dkmaa@hotmail.com
        • Contact:
        • Principal Investigator:
          • Dr,KHALID AL ANSARI, MD,FRCP,FAAP
        • Sub-Investigator:
          • WESSAM MOUHARAM, MD
      • Doha, Qatar, 3050
        • Recruiting
        • Pediatric Emergency Centre
        • Sub-Investigator:
          • WESSAM MOUHARAM, MD
        • Contact:
          • KHALID AL ANSARI, MD,FRCP,FAAP
          • Phone Number: 6006 97444396022
          • Email: dkmaa@hotmail.com
        • Contact:
        • Principal Investigator:
          • KHALID AL ANSARI, MD,FRCP,FAAP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• 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?
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: KHALID AL ANSARI, MD, SENIOR CONSULTANT-HEAD OF PEDIATRIC EMERGENCY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #12095/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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