Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis
Condition: Bronchiolitis; Magnesium, Abnormal Blood Level
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Magnesium Sulfate; placebo
Intervention type(s): Drug; Other
Intervention description(s): The use of magnesium sulfate intravenous in patient with bronchiolitis in pediatric emergency; follow Broncholitis severity score and length of stay; use of placebo with standard therapy
Other intervention name(s): normal saline for intravenous.
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bronchiolitis