search
Back to results

Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis

Primary Purpose

Bronchiolitis, Magnesium, Abnormal Blood Level

Status
Completed
Phase
Phase 2
Locations
Qatar
Study Type
Interventional
Intervention
Magnesium Sulfate
placebo
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring bronchiolitis

Eligibility Criteria

1 Month - 18 Months (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Pediatric Emergency Center, Al Saad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium sulfate

placebo

Arm Description

Magnesium sulfate. Single dose intravenous over one hour.

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.

Outcomes

Primary Outcome Measures

Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate

Secondary Outcome Measures

Improvement of bronchiolitis clinical severity score
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

Full Information

First Posted
January 28, 2014
Last Updated
August 14, 2016
Sponsor
Hamad Medical Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02145520
Brief Title
Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis
Official Title
Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Magnesium, Abnormal Blood Level
Keywords
bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium sulfate
Arm Type
Experimental
Arm Description
Magnesium sulfate. Single dose intravenous over one hour.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
The use of magnesium sulfate intravenous in patient with bronchiolitis in pediatric emergency; follow Broncholitis severity score and length of stay
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
normal saline for intravenous.
Intervention Description
use of placebo with standard therapy
Primary Outcome Measure Information:
Title
Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate
Time Frame
Time to medical readiness for discharge
Secondary Outcome Measure Information:
Title
Improvement of bronchiolitis clinical severity score
Description
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
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: obtunded consciousness progressive respiratory failure requiring intensive care unit (PICU) admission; history of apnea within 24 hours before presentation 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid M Al-Ansai, MD
Organizational Affiliation
HMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafah F Sayyed, MD
Organizational Affiliation
HMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Emergency Center, Al Saad
City
Doha
ZIP/Postal Code
465934
Country
Qatar

12. IPD Sharing Statement

Citations:
PubMed Identifier
28286262
Citation
Alansari K, Sayyed R, Davidson BL, Al Jawala S, Ghadier M. IV Magnesium Sulfate for Bronchiolitis: A Randomized Trial. Chest. 2017 Jul;152(1):113-119. doi: 10.1016/j.chest.2017.03.002. Epub 2017 Mar 9.
Results Reference
derived

Learn more about this trial

Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis

We'll reach out to this number within 24 hrs