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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
NCT02455687 |
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Date of registration:
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25/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.
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Scientific title:
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Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose With/Without Nebulized Budesonide for the Emergency Management of the Severe Asthma. A Randomized Controlled Trial. |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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240 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02455687 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Qatar
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Contacts
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Name:
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Khalid Alansari, MD |
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Address:
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Telephone:
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+974-55336166 |
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Email:
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kalansari@hamad.qa |
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Affiliation:
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Name:
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Khalid Alansari, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sidra Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Children 2-14 years of age.
2. Known to have bronchial asthma.
3. Presenting in severe asthma exacerbation
4. Asthma severity score 8 or higher according to PRAM asthma severity .
Exclusion Criteria:
1. Prematurity <34 weeks of gestation.
2. Critically ill children requiring immediate intubation or ICU admission.
3. Transfers from other institutions.
4. Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide,
prednisone, prednisolone, methylprednisolone, or magnesium sulfate.
5. History of neuromuscular disease, cardiac disease, renal disease, liver disease.
6. Underlying chronic lung disease.
7. Radiographic evidence of pneumonia or lung collapse .
8. Hemodynamic instability.
9. Instrumented airway or Tracheotomy.
10. Colostomy or ileostomy.
11. Malabsorption disorder.
12. Known vitamin D deficiency.
13. Receiving Milk of Magnesium for Constipation
14. Chronic diarrhea (duration for 2 weeks)
15. Diuretics use.
16. Immunodeficiency.
Age minimum:
2 Years
Age maximum:
14 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bronchial Asthma
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Intervention(s)
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Drug: Nebulized normal saline
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Drug: Std-dose iv MgSO4
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Drug: Hi-dose iv MgSO4
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Drug: Nebulized budesonide
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Primary Outcome(s)
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Time to medical readiness for discharge.
[Time Frame: 3 years]
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Secondary Outcome(s)
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Comparison of clinical response in severity score (%)
[Time Frame: 3 years]
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Frequency of need for revisit and readmission to pediatric emergency center for same diagnosis(%)
[Time Frame: 3 years]
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Overall length of the hospital stay (hours/days) .
[Time Frame: 3 years]
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The rate of admission to pediatric intensive care unit (%)
[Time Frame: 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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