Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis
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|ClinicalTrials.gov Identifier: NCT02145520|
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : August 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Magnesium, Abnormal Blood Level||Drug: Magnesium Sulfate Other: placebo||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||December 2015|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145520
|Pediatric Emergency Center, Al Saad|
|Doha, Qatar, 465934|
|Principal Investigator:||Khalid M Al-Ansai, MD||HMC|
|Principal Investigator:||Rafah F Sayyed, MD||HMC|