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Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02145520
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : August 16, 2016
Information provided by (Responsible Party):
Hamad Medical Corporation

Brief Summary:
In this study, investigators will compare the efficacy and safety of intravenous (IV) Magnesium sulfate in decreasing bronchiolitis clinical severity score and the duration of hospitalization in admitted patients, as compared to placebo.

Condition or disease Intervention/treatment Phase
Bronchiolitis Magnesium, Abnormal Blood Level Drug: Magnesium Sulfate Other: placebo Phase 2

Detailed Description:
  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Other: placebo
use of placebo with standard therapy
Other Name: normal saline for intravenous.

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

Secondary Outcome Measures :
  1. Improvement of bronchiolitis clinical severity score [ Time Frame: 2 Weeks ]
    1. Need for admission to ICU during the initial visit
    2. Within 2 weeks after discharge:

      1. Need for clinical revisit
      2. Need for infirmary/observation unit admission
      3. Need for ICU admission

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT02145520

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Pediatric Emergency Center, Al Saad
Doha, Qatar, 465934
Sponsors and Collaborators
Hamad Medical Corporation
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Principal Investigator: Khalid M Al-Ansai, MD HMC
Principal Investigator: Rafah F Sayyed, MD HMC

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hamad Medical Corporation Identifier: NCT02145520    
Other Study ID Numbers: 12216/12
12216/12 ( Other Identifier: Hamad Medical Corporation )
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: March 2015
Keywords provided by Hamad Medical Corporation:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents