Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis

• Register: ClinicalTrials.gov
• Last refreshed on: 22 August 2016
• Main ID: NCT02145520
• Date of registration: 28/01/2014
• Prospective Registration: No
• Primary sponsor: Hamad Medical Corporation
• Public title: Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis
• Scientific title: Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.
• Date of first enrolment: October 2012
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02145520
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Qatar

Contacts

• Name: Khalid M Al-Ansai, MD
• Affiliation: HMC

• Name: Rafah F Sayyed, MD
• Affiliation: HMC

Key inclusion & exclusion criteria

Inclusion Criteria:

Infants 1-18 months of age presenting to Al Saad Pediatric Emergency Center from October
2012 to May 2015 with diagnosis of Bronchiolitis and bronchiolitis clinical severity score
> 4,will be include in the study.

Exclusion Criteria:

- Prematurity (Gestational age 34 weeks or less);

- Previous history of wheezing;

- Use of steroid within 48 hours of presentation;

- CRITICALLY ill patients with one or more of the following:

1. obtunded consciousness

2. progressive respiratory failure requiring intensive care unit (PICU) admission;

3. history of apnea within 24 hours before presentation

4. oxygen saturation < 85% on room air at the time of recruitment

- History of chronic lung disease;Chronic lung disease of prematurity Cystic fibrosis;

- Congenital heart disease.

- All immunodeficient children: primary or secondary

- Known hypersensitivity to magnesium sulfate.

- Known to have magnesium or calcium metabolism disturbance. (e.g.; vitamin D
deficiency, hypoparathyroidism).



Age minimum: 1 Month
Age maximum: 18 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Magnesium, Abnormal Blood Level

Bronchiolitis

Intervention(s)

Drug: Magnesium Sulfate

Other: placebo

Primary Outcome(s)

Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate [Time Frame: Time to medical readiness for discharge]

Secondary Outcome(s)

Improvement of bronchiolitis clinical severity score [Time Frame: 2 Weeks]

Secondary ID(s)

12216/12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors