Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis
|Bronchiolitis Magnesium, Abnormal Blood Level||Drug: Magnesium Sulfate Other: placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.|
- Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate [ Time Frame: Time to medical readiness for discharge ]
- Improvement of bronchiolitis clinical severity score [ Time Frame: 2 Weeks ]
- Need for admission to ICU during the initial visit
Within 2 weeks after discharge:
- Need for clinical revisit
- Need for infirmary/observation unit admission
- Need for ICU admission
|Study Start Date:||October 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Magnesium sulfate
Magnesium sulfate. Single dose intravenous over one hour.
Drug: Magnesium Sulfate
The use of magnesium sulfate intravenous in patient with bronchiolitis in pediatric emergency; follow Broncholitis severity score and length of stay
Placebo Comparator: placebo
Treatment will be delivered to enrolled patients as currently practice in PEC (Epinephrine nebulization +5%hypertonic saline with/without dexamethasone).
•All patients will be randomized to receive either Magnesium sulfate over 1 hour or placebo.•Bronchiolitis severity score (BSS) will be recorded at 0, 4, 8, 12, 16,20,24,36,48,60,72 hours, and on discharge.
use of placebo with standard therapy
Other Name: normal saline for intravenous.
- On arrival to Pediatric Emergency Center, patients will be attended by a pediatric specialist on call who will take history and perform full physical examination. Patients will be assessed for eligibility to the study based on the inclusion criteria.
- Guardians of eligible patients will be approached with the study design, objectives and risks; Patients will be included after obtaining a verbal and assigned written consent.
- A chest radiograph and Magnesium level in serum will be requested for all study patients upon recruitment.
- The observation physician will complete the data collection sheet that will include the patient's demographics, physical examination, bronchiolitis clinical severity score,oxygen saturation, chest radiograph findings and Magnesium level.
- Treatment will be delivered to enrolled patients as currently practice in PEC(Nebulized epinephrine 1:1000 1ml in 5 ml of 5% hypertonic saline, every 4 hours until discharge, for all patients and if there is history of Bronchial Asthma in mother, father or full sibling. And/or history of Eczema in the Child ,patients will start on dexamethasone 1mg/kg orally stat.(max-10 mg/dose). Then 0,6 mg/kg orally once daily starting from second day of admission for 4 days).
- All patients will be randomized to receive either Magnesium sulfate intravenous single dose over 1 hour or placebo. And it will be given in the same time with currently practice treatment
- Epinephrine nebulization can be given on PRN basis up to a maximum of every one hour, at a dose of 0.5 mg/kg (min 2.5mg/dose and max 5 mg/dose) mixed in 5 ml of 5% hypertonic saline.•
- Bronchiolitis severity score (BSS) will be recorded at 0, 4, 8, 12, 16,20,24,36,48,60,72 hours, and on discharge.
- Vital signs will be recorded at 0, 2, 4 hours and then every 4 hours from the administration of study medication.
- All patients will be followed up for two weeks post discharge by a phone call asking about the general condition, relapse of symptoms, or need for readmission.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02145520
|Pediatric Emergency Center, Al Saad|
|Doha, Qatar, 465934|
|Principal Investigator:||Khalid M Al-Ansai, MD||HMC|
|Principal Investigator:||Rafah F Sayyed, MD||HMC|