Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma
1 other identifier
interventional
400
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Dec 2012
Typical duration for not_applicable asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
April 25, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 28, 2014
January 1, 2014
2.2 years
April 17, 2012
January 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma significantly reduce the time to clinical readiness for discharge?
36 months
Secondary Outcomes (1)
• Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease admission and readmission rate, compared to placebo
36 months
Study Arms (2)
magnesium sulfate arm
OTHERmagnesium sulfate with standard therapy
placebo arm
NO INTERVENTIONplacebo with standard therapy
Interventions
Eligibility Criteria
You may qualify if:
- Pediatric asthma patients with moderate to severe exacerbation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hamad Medical Corporation
Doha, Qatar, 3050, Qatar
Pediatric Emergency Centre
Doha, 3050, Qatar
Related Publications (1)
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.
PMID: 25652104DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KHALID AL ANSARI, MD
SENIOR CONSULTANT-HEAD OF PEDIATRIC EMERGENCY
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2012
First Posted
April 25, 2012
Study Start
December 1, 2012
Primary Completion
March 1, 2015
Study Completion
December 1, 2015
Last Updated
January 28, 2014
Record last verified: 2014-01