<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04465175</url>
  </required_header>
  <id_info>
    <org_study_id>Mag4As</org_study_id>
    <nct_id>NCT04465175</nct_id>
  </id_info>
  <brief_title>Double Dose Magnesium Sulphate in Moderate-severe Asthma in Paediatrics</brief_title>
  <official_title>Single Versus Double Dose Magnisum Sulphate in the Treatment of Moderate to Severe Asthma in Children in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oman Medical Speciality Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oman Medical Speciality Board</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction : . In Oman the prevalence of asthma was estimated to be 7.3% of adults and&#xD;
      12.7% of children . Magnesium sulphate is the second line treatment, many studies had shown&#xD;
      that it has beneficial effect in treating acute asthma in children ; it reduces the hospital&#xD;
      stay and the rate of admission as well as the ventilation rate .&#xD;
&#xD;
      Aim : To compare single dose Magnesium sulphate that is typically given in the emergency&#xD;
      department verses two doses of magnesium sulphate in treating acute moderate-severe asthma&#xD;
      exacerbation in paediatric age group Research hypothesis : Children who are treated with two&#xD;
      doses MgSO4 are more likely to have improvement in their PRAM score and are less likely to be&#xD;
      admitted to the ward, HD or ICU Primary outcome : Improvement in PRAM (Paediatric respiratory&#xD;
      assessment measure) score of acute asthma exacerbation Secondary outcome : Reduce admission&#xD;
      rate to general ward, PICU and HD . Demonstrate the safety profile of double dose of&#xD;
      magnesium sulphate.&#xD;
&#xD;
      Study Design : prospective blinded randomized trial&#xD;
&#xD;
      Study population : children age 3-13 years who presented to Royal hospital paediatric&#xD;
      emergency with moderate-severe acute asthma&#xD;
&#xD;
      Intervention : two doses magnesium sulphate&#xD;
&#xD;
      Comparison : Placebo&#xD;
&#xD;
      Outcome : Improvement in PRAM score&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research questions :&#xD;
&#xD;
      In children 3 to 13 years of age presenting to the pediatric emergency room with moderate to&#xD;
      severe asthma exacerbation, does double dose Magnesium sulfate improve asthma severity (PRAM)&#xD;
      score and reduce admission rate more than single dose?&#xD;
&#xD;
      Study design :&#xD;
&#xD;
      Prospective double-blinded randomized clinical trial in paediatric (from age 3-13 years) who&#xD;
      presents to the emergency department (ED) at Sultan Royal hospital with moderate to severe&#xD;
      Acute asthma (PRAM score &gt;=5) , Consent will be obtained from the parents. Eligible subjects&#xD;
      will be enrolled Control Group Will receive second dose magnesium sulphate (50 mg/kg over 1&#xD;
      hour = 2.5mllkg) Intervention Group Will receive Normal saline (2.5ml/kg over 1 hour )&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      90 patient will be needed ( 45 on each arm) to have 60% power to detect a difference on PRAM&#xD;
      score between the groups at the 5% alpha (significance) level.&#xD;
&#xD;
      Study steps:&#xD;
&#xD;
        1. Initial nursing triage for all acute asthma exacerbation , initial PRAM score will be&#xD;
           recorded&#xD;
&#xD;
        2. Initial standard management as per protocol , which includes :&#xD;
&#xD;
             1. Oxygen if indicated&#xD;
&#xD;
             2. Back to back salbutamol (2.5-5 mg) and ipratropium (0.25-0.5 mg )nebulization OR&#xD;
                salbutamol MDI 5 puffs (wt 10 Kg) -&#xD;
&#xD;
             3. Systemic corticosteroid : children with PRAM 5-8 give oral dexamethasone 0.3 mg/kg&#xD;
                , those with PRAM score 9-12 give hydrocortisone 4 mg/kg IV&#xD;
&#xD;
        3. Child will reassessed after the initial measures , PRAM score will be recorded in the&#xD;
           patient sheet&#xD;
&#xD;
        4. All children with persistent PRAM score of ≥ 5 will receive the first dose of magnesium&#xD;
           sulphate ( 50 mg/kg over 20 minutes&#xD;
&#xD;
        5. After 30 minutes of the first dose Magnesium sulphate PRAM score will be recorded,&#xD;
           during this period child will be given 20ml/hr normal saline&#xD;
&#xD;
        6. Children with persistent PRAM score ≥ 5 will be included in the study provided they met&#xD;
           the inclusion and exclusion criteria (as mentioned below ) ,consent will be obtained&#xD;
           from parents&#xD;
&#xD;
        7. If the child met the inclusion and exclusion criteria , the treating physician will pick&#xD;
           one envelope from the research box , each envelope will have serial or sequencing number&#xD;
           for the medications (saline or MgSO4 )&#xD;
&#xD;
        8. The pharmacist will prepare a 100 ml bags that contains either saline or 2 grams&#xD;
           magnesium sulphate in 100ml. The content will be concealed from the treating physician&#xD;
           by the pharmacist.&#xD;
&#xD;
        9. Child be will given 2.5 ml/kg from any bag chosen (based on the sequencing) . The total&#xD;
           amount will be infused over one hour.&#xD;
&#xD;
       10. PRAM score post intervention will be recorded . Disposition will be based on physician&#xD;
           assessment and improvement in PRAM score&#xD;
&#xD;
       11. Safety Assessments : All adverse events will be documented on an side effect section on&#xD;
           patient's sheet case . Serious adverse events should be immediately reported to the&#xD;
           primary investigator. Any serious, adverse event will be reported immediately to the&#xD;
           Institutional Review Board.&#xD;
&#xD;
      Reported side effects for magnesium sulphte : nausea ,facial warmth , flushing , pain and&#xD;
      numbness at infusion site , dry mouth and malaise . Rare side effect : hypotension&#xD;
&#xD;
      Beneficiaries of the research :&#xD;
&#xD;
        -  To the child :&#xD;
&#xD;
             -  Improvement in his/her symptoms&#xD;
&#xD;
             -  Reduce PICU admission and intubation&#xD;
&#xD;
             -  Reduce the abstinences from school and improve the quality of life&#xD;
&#xD;
        -  To the health system:&#xD;
&#xD;
             -  Availability of PICU and HDU beds for more sick patients&#xD;
&#xD;
             -  Reducing the cost of asthmatic patient care&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma</measure>
    <time_frame>at 60 minutes of intervention</time_frame>
    <description>Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma exacerbation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduce admission rate to general ward, paediatric intensive care unit and high dependency unit</measure>
    <time_frame>during first 24 hours</time_frame>
    <description>Reduce admission rate to general ward, paediatric intensive care unit and high dependency unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demonstrate the safety profile of double dose of magnesium sulphate.</measure>
    <time_frame>during first 24 hours</time_frame>
    <description>Any side effects from giving second doses Magnesium sulphate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Asthma in Children</condition>
  <arm_group>
    <arm_group_label>Second dose magnesium sulphate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Second dose magnesium sulphate 50 mg/kg infused over one hour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline (2.5 ml/kg) infused over one hour</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate</intervention_name>
    <description>Second dose magnesium sulphate infusion over one hour</description>
    <arm_group_label>Second dose magnesium sulphate</arm_group_label>
    <other_name>MgSO4</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline (2.5 ml/kg) infusion over one hour</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physican diagnosed of asthma&#xD;
&#xD;
          -  Age 3-13 years&#xD;
&#xD;
          -  Children presenting with acute moderate- severe asthma (PRAM score ≥ 5)&#xD;
&#xD;
          -  Failed to respond to initial treatment of acute asthma&#xD;
&#xD;
          -  Not known to have allergy from MgSO4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mild exacerbation of asthma (initial PRAM score ≤4)&#xD;
&#xD;
          -  Other comorbid present : Significant heart disease , arrhythmias , chronic kidney&#xD;
             disease , cystic fibrosis , operated trachea-esophageal fistula , known or operated&#xD;
             for vascular ring , trisomy 21&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noora Al-Alawi, Resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oman Medical Specialty Board</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Noora AL-Alawi, Resident</last_name>
    <phone>+968 95938322</phone>
    <email>noora.a18@resident.omsb.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Saed Al-Obedani</last_name>
    <phone>+968 99352024</phone>
    <email>saeedem@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oman Medical Speciality Board</investigator_affiliation>
    <investigator_full_name>Noora Nasser Al-Alawi</investigator_full_name>
    <investigator_title>Emergency resident -Oman medical specialty board</investigator_title>
  </responsible_party>
  <keyword>asthma , Magnesium sulphate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04465175
org study id: Mag4As
nct id: NCT04465175
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
Research questions :

      In children 3 to 13 years of age presenting to the pediatric emergency room with moderate to
      severe asthma exacerbation, does double dose Magnesium sulfate improve asthma severity (PRAM)
      score and reduce admission rate more than single dose?

      Study design :

      Prospective double-blinded randomized clinical trial in paediatric (from age 3-13 years) who
      presents to the emergency department (ED) at Sultan Royal hospital with moderate to severe
      Acute asthma (PRAM score >=5) , Consent will be obtained from the parents. Eligible subjects
      will be enrolled Control Group Will receive second dose magnesium sulphate (50 mg/kg over 1
      hour = 2.5mllkg) Intervention Group Will receive Normal saline (2.5ml/kg over 1 hour )

      Sample size:

      90 patient will be needed ( 45 on each arm) to have 60% power to detect a difference on PRAM
      score between the groups at the 5% alpha (significance) level.

      Study steps:

        1. Initial nursing triage for all acute asthma exacerbation , initial PRAM score will be
           recorded

        2. Initial standard management as per protocol , which includes :

             1. Oxygen if indicated

             2. Back to back salbutamol (2.5-5 mg) and ipratropium (0.25-0.5 mg )nebulization OR
                salbutamol MDI 5 puffs (wt 10 Kg) -

             3. Systemic corticosteroid : children with PRAM 5-8 give oral dexamethasone 0.3 mg/kg
                , those with PRAM score 9-12 give hydrocortisone 4 mg/kg IV

        3. Child will reassessed after the initial measures , PRAM score will be recorded in the
           patient sheet

        4. All children with persistent PRAM score of ≥ 5 will receive the first dose of magnesium
           sulphate ( 50 mg/kg over 20 minutes

        5. After 30 minutes of the first dose Magnesium sulphate PRAM score will be recorded,
           during this period child will be given 20ml/hr normal saline

        6. Children with persistent PRAM score ≥ 5 will be included in the study provided they met
           the inclusion and exclusion criteria (as mentioned below ) ,consent will be obtained
           from parents

        7. If the child met the inclusion and exclusion criteria , the treating physician will pick
           one envelope from the research box , each envelope will have serial or sequencing number
           for the medications (saline or MgSO4 )

        8. The pharmacist will prepare a 100 ml bags that contains either saline or 2 grams
           magnesium sulphate in 100ml. The content will be concealed from the treating physician
           by the pharmacist.

        9. Child be will given 2.5 ml/kg from any bag chosen (based on the sequencing) . The total
           amount will be infused over one hour.

       10. PRAM score post intervention will be recorded . Disposition will be based on physician
           assessment and improvement in PRAM score

       11. Safety Assessments : All adverse events will be documented on an side effect section on
           patient's sheet case . Serious adverse events should be immediately reported to the
           primary investigator. Any serious, adverse event will be reported immediately to the
           Institutional Review Board.

      Reported side effects for magnesium sulphte : nausea ,facial warmth , flushing , pain and
      numbness at infusion site , dry mouth and malaise . Rare side effect : hypotension

      Beneficiaries of the research :

        -  To the child :

             -  Improvement in his/her symptoms

             -  Reduce PICU admission and intubation

             -  Reduce the abstinences from school and improve the quality of life

        -  To the health system:

             -  Availability of PICU and HDU beds for more sick patients

             -  Reducing the cost of asthmatic patient care
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma
time frame: at 60 minutes of intervention
description: Improvement in PRAM (Paediatric respiratory assessment measure) score of acute asthma exacerbation
measure: Reduce admission rate to general ward, paediatric intensive care unit and high dependency unit
time frame: during first 24 hours
description: Reduce admission rate to general ward, paediatric intensive care unit and high dependency unit
measure: Demonstrate the safety profile of double dose of magnesium sulphate.
time frame: during first 24 hours
description: Any side effects from giving second doses Magnesium sulphate
arm group label: Second dose magnesium sulphate
arm group type: Active Comparator
description: Second dose magnesium sulphate 50 mg/kg infused over one hour
arm group label: Placebo
arm group type: Placebo Comparator
description: Normal saline (2.5 ml/kg) infused over one hour
intervention type: Drug
intervention name: Magnesium Sulfate
description: Second dose magnesium sulphate infusion over one hour
arm group label: Second dose magnesium sulphate
other name: MgSO4
intervention type: Drug
intervention name: Placebo
description: Normal saline (2.5 ml/kg) infusion over one hour
arm group label: Placebo
other name: Normal saline
criteria: 
gender: All
minimum age: 3 Years
maximum age: 13 Years
healthy volunteers: No
last name: Noora Al-Alawi, Resident
role: Principal Investigator
affiliation: Oman Medical Specialty Board
last name: Noora AL-Alawi, Resident
phone: +968 95938322
email: noora.a18@resident.omsb.org
last name: Saed Al-Obedani
phone: +968 99352024
email: saeedem@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Oman Medical Speciality Board
investigator full name: Noora Nasser Al-Alawi
investigator title: Emergency resident -Oman medical specialty board
mesh term: Asthma
mesh term: Magnesium Sulfate
sharing ipd: No