Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma

Sponsor

Hamad Medical Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01584726

Collaborator

(none)

400

Enrollment

Locations

Arms

Duration (Months)

200

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Magnesium Sulfate	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

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? [36 months]

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 [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?

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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