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Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT02145520
First received: January 28, 2014
Last updated: August 14, 2016
Last verified: March 2015
  Purpose
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 Intervention Phase
Bronchiolitis
Magnesium, Abnormal Blood Level
Drug: Magnesium Sulfate
Other: placebo
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Hamad Medical Corporation:

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

Secondary Outcome Measures:
  • 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


Enrollment: 200
Study Start Date: October 2012
Study Completion Date: December 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   1 Month to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02145520

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

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT02145520     History of Changes
Other Study ID Numbers: 12216/12
12216/12 ( Other Identifier: Hamad Medical Corporation )
Study First Received: January 28, 2014
Last Updated: August 14, 2016

Keywords provided by Hamad Medical Corporation:
bronchiolitis

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 27, 2017