Clinical trial NCT02145520: Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis
Official title: Efficacy of Magnesium Sulfate in the Treatment of Bronchiolitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchiolitis
Magnesium, Abnormal Blood Level
Keywords: bronchiolitis
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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).

Primary outcomes:
measure: Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate
timeFrame: Time to medical readiness for discharge
Secondary outcomes:
measure: Improvement of bronchiolitis clinical severity score
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Pediatric Emergency Center, Al Saad
Study officials:
affiliation: HMC
name: Khalid M Al-Ansai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HMC
name: Rafah F Sayyed, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.