Double Dose Magnesium Sulphate in Moderate-severe Asthma in Paediatrics

NCT04465175 | Unknown Phase 2

• 1 other identifier: Mag4As
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction : . In Oman the prevalence of asthma was estimated to be 7.3% of adults and 12.7% of children . Magnesium sulphate is the second line treatment, many studies had shown that it has beneficial effect in treating acute asthma in children ; it reduces the hospital stay and the rate of admission as well as the ventilation rate . Aim : To compare single dose Magnesium sulphate that is typically given in the emergency department verses two doses of magnesium sulphate in treating acute moderate-severe asthma exacerbation in paediatric age group Research hypothesis : Children who are treated with two doses MgSO4 are more likely to have improvement in their PRAM score and are less likely to be admitted to the ward, HD or ICU Primary outcome : Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma exacerbation Secondary outcome : Reduce admission rate to general ward, PICU and HD . Demonstrate the safety profile of double dose of magnesium sulphate. Study Design : prospective blinded randomized trial Study population : children age 3-13 years who presented to Royal hospital paediatric emergency with moderate-severe acute asthma Intervention : two doses magnesium sulphate Comparison : Placebo Outcome : Improvement in PRAM score

Conditions

Asthma in Children

Keywords

asthma , Magnesium sulphate

Outcome Measures

Primary Outcomes (1)

• Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma

  Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma exacerbation

  at 60 minutes of intervention

Secondary Outcomes (2)

• Reduce admission rate to general ward, paediatric intensive care unit and high dependency unit

  during first 24 hours

• Demonstrate the safety profile of double dose of magnesium sulphate.

  during first 24 hours

Study Arms (2)

Second dose magnesium sulphate

ACTIVE COMPARATOR

Second dose magnesium sulphate 50 mg/kg infused over one hour

Drug: Magnesium Sulfate

Placebo

PLACEBO COMPARATOR

Normal saline (2.5 ml/kg) infused over one hour

Drug: Placebo

Interventions

Magnesium Sulfate DRUG

Second dose magnesium sulphate infusion over one hour

Also known as: MgSO4

Second dose magnesium sulphate

Placebo DRUG

Normal saline (2.5 ml/kg) infusion over one hour

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Physican diagnosed of asthma
• Age 3-13 years
• Children presenting with acute moderate- severe asthma (PRAM score ≥ 5)
• Failed to respond to initial treatment of acute asthma
• Not known to have allergy from MgSO4

You may not qualify if:

• Mild exacerbation of asthma (initial PRAM score ≤4)
• Other comorbid present : Significant heart disease , arrhythmias , chronic kidney disease , cystic fibrosis , operated trachea-esophageal fistula , known or operated for vascular ring , trisomy 21

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

MeSH Terms

Conditions

Asthma

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Noora Al-Alawi, Resident

  Oman Medical Specialty Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noora AL-Alawi, Resident

CONTACT

+968 95938322; noora.a18@resident.omsb.org

Saed Al-Obedani

CONTACT

+968 99352024; saeedem@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency resident -Oman medical specialty board

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 9, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share