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Completed

NCT Number: NCT02145520

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.

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Key information

Age range

1 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pediatric Emergency Center, Al Saad

Doha, Qatar, 465934

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Magnesium sulfate

Drug

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

Placebo

Other

use of placebo with standard therapy

Other names: normal saline for intravenous.

Primary outcomes

  1. Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate

    Time frame: Time to medical readiness for discharge

Secondary outcomes

  1. Improvement of bronchiolitis clinical severity score

    Time frame: 2 Weeks

    • 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

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 23, 2014
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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