Status:
COMPLETED
Magnesium Nebulization Utilization in Management of Pediatric Asthma
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Alberta Children's Hospital
Conditions:
Acute Asthma
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
Acute asthma is the most common cause of pediatric hospitalizations. While the investigators know that repeat inhalations of ß2 agonists and ipratropium with early oral steroids substantially reduce h...
Detailed Description
The investigators plan the following specific aims: 1. Primary Objective: To examine if in children with acute asthma remaining in moderate to severe respiratory distress despite maximized initial br...
Eligibility Criteria
Inclusion
- 2-17 years of age
- Diagnosis of asthma/reactive airways/viral wheeze, defined as this diagnosis made by a physician and at least one prior acute episode of wheezing with cough or dyspnea treated with inhaled ß2 agonists or oral corticosteroids. Our study population will exclude bronchiolitis and first-time wheeze (potential alternate diagnoses).
- Persistent moderate to severe airway obstruction after 3 doses of salbutamol and ipratropium (as per site specific standard of care guidelines) -, defined as a PRAM 5 or higher. A PRAM score of 5 or more following initial therapy indicates the child has at least moderate disease severity and has a high likelihood of being hospitalized.This group of children includes 84% of all pediatric asthma hospitalizations; therefore, finding an effective therapy for this population has great potential to significantly reduce hospitalizations. (Appendix B).
Exclusion
- No previous history of wheezing or bronchodilator therapy. Some children who present with wheezing for the first time will have other diagnoses which would not be expected to respond to Mg.
- Patients who have already received IV Mg therapy during the index visit.
- Critically ill children requiring immediate intubation. These children need immediate ICU management and hospitalization.
- Children who in the opinion of the treating physician require a chest radiograph due to atypical clinical presentation and are found to have radiologist-confirmed pneumonia. These rare patients may have to be hospitalized primarily for treatment of the infection and may not respond to magnesium.
- Known co-existent renal, chronic pulmonary, neurologic, cardiac or systemic disease. These conditions may influence the response to Mg and hospitalization.
- Known hypersensitivity to Mg sulfate.
- Patients previously enrolled in the study.
- Insufficient command of the English and or French language.
- Lack of a home or cellular telephone.
- Known allergy/sensitivity to latex.
Key Trial Info
Start Date :
September 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2019
Estimated Enrollment :
818 Patients enrolled
Trial Details
Trial ID
NCT01429415
Start Date
September 26 2011
End Date
November 22 2019
Last Update
April 2 2020
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
2
Stollery Hospital
Edmonton, Alberta, Canada, T6G1C9
3
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
4
The Manitoba Institute of Child Health
Winnipeg, Manitoba, Canada, R3E3P4