Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145520
• Other study ID #: 12216/12
• Secondary ID: 12216/12
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2014
• Last updated: August 14, 2016
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Qatar: Hamad Medical Corporation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 18 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Magnesium, Abnormal Blood Level

Intervention

Drug:
• Magnesium Sulfate
The use of magnesium sulfate intravenous in patient with bronchiolitis in pediatric emergency; follow Broncholitis severity score and length of stay

Other:
• placebo
use of placebo with standard therapy

Locations

Country	Name	City	State
Qatar	Pediatric Emergency Center, Al Saad	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate		Time to medical readiness for discharge	Yes
Secondary	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	2 Weeks	Yes