Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis

August 14, 2016 updated by: Hamad Medical Corporation

Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar, 465934
        • Pediatric Emergency Center, Al Saad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • normal saline for intravenous.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate
Time Frame: Time to medical readiness for discharge
Time to medical readiness for discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: Khalid M Al-Ansai, MD, HMC
  • Principal Investigator: Rafah F Sayyed, MD, HMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

May 22, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 14, 2016

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12216/12 (Other Identifier: Hamad Medical Corporation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchiolitis

Clinical Trials on Magnesium Sulfate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe