<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/NCT03831568</url>
  </required_header>
  <id_info>
    <org_study_id>MIE 2016_14321</org_study_id>
    <secondary_id>17/9232</secondary_id>
    <secondary_id>Hov_2017</secondary_id>
    <nct_id>NCT03831568</nct_id>
  </id_info>
  <brief_title>Mechanical Cough Augmentation in Children With NMD</brief_title>
  <official_title>Prevalence and Use of Mechanical Cough Augmentation in Children With Neuromuscular Disorders in Norway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sorlandet Hospital HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</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>
      The study investigates the prevalence and use of mechanical insufflation - exsufflation&#xD;
      (MI-E) in children with Neuromuscular disorders (NMD) in Norway. The NMD related prevalence&#xD;
      of MIE use in Norway will be described and possible regional differences regarding use will&#xD;
      be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan&#xD;
      conditions. Respiratory tract infections and lung complications are the main causes of&#xD;
      increased morbidity and mortality.&#xD;
&#xD;
      The use of mechanical cough augmentation with insufflation-exsufflation (MIE) is a strategy&#xD;
      to treat and prevent. Possible major benefits are described, but optimal settings for best&#xD;
      efficacy and comfort in children are not established.&#xD;
&#xD;
      The main objective is to determine the prevalence and use of MIE among children with NMD in&#xD;
      Norway. All children with NMD &lt; 18 years which has received a machine for MI-E will be&#xD;
      invited to participate in the study.&#xD;
&#xD;
      The participants will be asked to complete two questionnaires. In addition will information&#xD;
      from the data card in the MI-E machines give information about use. The information will be&#xD;
      linked to the National register for Long term mechanical ventilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Residency</measure>
    <time_frame>At one point (1 day)</time_frame>
    <description>Name of county</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Indication for use</measure>
    <time_frame>At one point (1 day)</time_frame>
    <description>Prevention or treatment purposes from questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosis</measure>
    <time_frame>01.01.2018</time_frame>
    <description>International Classification of Diseases - 10 diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>One time at completion of questionaire</time_frame>
    <description>The DISABKIDS Chronic Generic Module (DCGM-37) is a questionnaire measuring general health-related quality of life (HRQoL) and the level of distress caused by a chronic disease at 3 domains (mental, social and physical) in 6 dimensions: Independence, Emotion, Social inclusion, Social exclusion, Limitation and Treatment. Each item is scored on a five-point Likert scale which indicates behavior or feelings as 1 = never, 2 = seldom, 3 = quite often, 4 = very often and 5 = always. There is one form to be filled in by children 8 to 18 years of age, and one form by their parents. The sum of scores within each dimension makes up the raw score, which is transformed linearly into a score ranging from 0 to 100. The scores are added and further transformed into a total HRQOL score with a range 0 to 100 with higher scores indicating higher HRQOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Settings in use</measure>
    <time_frame>One time at completion of questionaire</time_frame>
    <description>Recorded from data card in MIE machine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opinion on treatment</measure>
    <time_frame>One time at completion of questionaire</time_frame>
    <description>A purpose made questionnaire including questions with predefined categorical data in no order, and 2 questions using a Visual Analog Scale 0-10 to score perceived benefit of the treatment where 0 indicates not important at all and 10 indicates very important.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <condition>Children, Only</condition>
  <condition>Airway Clearance Impairment</condition>
  <condition>Cough</condition>
  <arm_group>
    <arm_group_label>Children with given device for mechanical cough</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children with neuromuscular disorder bellow 18 years that has received a machine for MI-E.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: ,&#xD;
&#xD;
          -  Received a MI-E device&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  &lt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vegard Hovland, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo university hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 27, 2017</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Brit Hov</investigator_full_name>
    <investigator_title>Physiotherapist, MSc</investigator_title>
  </responsible_party>
  <keyword>Airway management</keyword>
  <keyword>Cough</keyword>
  <keyword>Neuromuscular diseases</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Mechanical insufflation-exsufflation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cough</mesh_term>
    <mesh_term>Neuromuscular Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03831568
org study id: MIE 2016_14321
secondary id: 17/9232
secondary id: Hov_2017
nct id: NCT03831568
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The study investigates the prevalence and use of mechanical insufflation - exsufflation
      (MI-E) in children with Neuromuscular disorders (NMD) in Norway. The NMD related prevalence
      of MIE use in Norway will be described and possible regional differences regarding use will
      be assessed.
Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan
      conditions. Respiratory tract infections and lung complications are the main causes of
      increased morbidity and mortality.

      The use of mechanical cough augmentation with insufflation-exsufflation (MIE) is a strategy
      to treat and prevent. Possible major benefits are described, but optimal settings for best
      efficacy and comfort in children are not established.

      The main objective is to determine the prevalence and use of MIE among children with NMD in
      Norway. All children with NMD < 18 years which has received a machine for MI-E will be
      invited to participate in the study.

      The participants will be asked to complete two questionnaires. In addition will information
      from the data card in the MI-E machines give information about use. The information will be
      linked to the National register for Long term mechanical ventilation.
observational model: Other
time perspective: Prospective
measure: Residency
time frame: At one point (1 day)
description: Name of county
measure: Indication for use
time frame: At one point (1 day)
description: Prevention or treatment purposes from questionnaire
measure: Diagnosis
time frame: 01.01.2018
description: International Classification of Diseases - 10 diagnosis
measure: Health related quality of life
time frame: One time at completion of questionaire
description: The DISABKIDS Chronic Generic Module (DCGM-37) is a questionnaire measuring general health-related quality of life (HRQoL) and the level of distress caused by a chronic disease at 3 domains (mental, social and physical) in 6 dimensions: Independence, Emotion, Social inclusion, Social exclusion, Limitation and Treatment. Each item is scored on a five-point Likert scale which indicates behavior or feelings as 1 = never, 2 = seldom, 3 = quite often, 4 = very often and 5 = always. There is one form to be filled in by children 8 to 18 years of age, and one form by their parents. The sum of scores within each dimension makes up the raw score, which is transformed linearly into a score ranging from 0 to 100. The scores are added and further transformed into a total HRQOL score with a range 0 to 100 with higher scores indicating higher HRQOL.
measure: Settings in use
time frame: One time at completion of questionaire
description: Recorded from data card in MIE machine
measure: Opinion on treatment
time frame: One time at completion of questionaire
description: A purpose made questionnaire including questions with predefined categorical data in no order, and 2 questions using a Visual Analog Scale 0-10 to score perceived benefit of the treatment where 0 indicates not important at all and 10 indicates very important.
arm group label: Children with given device for mechanical cough
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Vegard Hovland, PhD
role: Principal Investigator
affiliation: MD
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Brit Hov
investigator title: Physiotherapist, MSc
mesh term: Cough
mesh term: Neuromuscular Diseases