Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01584726
• Other study ID #: #12095/12
• Status: Recruiting
• Phase: N/A
• First received: April 17, 2012
• Last updated: January 27, 2014
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2014
• Source: Hamad Medical Corporation
• Contact: Dr. Khalid Al Ansari, MD,FRCP,FAAP
• Phone: 97444396001
• Email: dkmaa[@]hotmail.com
• Is FDA regulated: No
• Health authority: Qatar: Hamad Medical Corporation
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Magnesium Sulfate
single dose of magnesium sulfate nebulization

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha
Qatar	Pediatric Emergency Centre	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	• 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?	36 months	No