<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/NCT04440111</url>
  </required_header>
  <id_info>
    <org_study_id>PI19/490</org_study_id>
    <nct_id>NCT04440111</nct_id>
  </id_info>
  <brief_title>Basic Life Support by Children</brief_title>
  <official_title>Teaching Children Basic Life Support: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cristina Genzor</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Miguel Servet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto de Investigación Sanitaria Aragón</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A controlled clinical trial will be performed.&#xD;
&#xD;
      School children from the age of 10 to 11 will be selected to learn basic life support (BLS)&#xD;
      in a primary school of Zaragoza.&#xD;
&#xD;
      One of the groups will learn BLS in two consecutive years and the other group will learn BLS&#xD;
      only the first year.&#xD;
&#xD;
      The investigators think that the knowledge will be better in the group that receives two&#xD;
      interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A controlled clinical trial will be performed.&#xD;
&#xD;
      72 participants between 10 and 11 years old will be selected and randomized to participate.&#xD;
&#xD;
      Control group and experimental group will enrolled 36 participants each one. Control group&#xD;
      will receive BLS training once. Experimental group will receive BLS training in two&#xD;
      consecutive years.&#xD;
&#xD;
      Previous and after training a test will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 11, 2020</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Actual">February 27, 2020</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the knowledge level of BLS after receiving one or two interventions</measure>
    <time_frame>3 hours</time_frame>
    <description>A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To compare test results obtained previous and after intervention.</measure>
    <time_frame>1 month</time_frame>
    <description>A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015. After obteining the marks, the results will be compared using Statistical Analysis Software.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Cardiopulmonary Arrest With Successful Resuscitation</condition>
  <condition>Child, Only</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One year basic life support training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Two years basic life support training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>One year training</intervention_name>
    <description>At first, children will make a test to evaluate their pre- intervention basic support life knowledge.&#xD;
Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015.&#xD;
After that, they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will only make the test, they won't receive any theory or practice.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>One year basic life support training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Two years training</intervention_name>
    <description>At first, children will make a test to evaluate their pre- intervention basic support life knowledge.&#xD;
Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that they will make a practical workshop on BLS.&#xD;
Finally they will repeat the initial test. The second year, this group will repeat the same process.</description>
    <arm_group_label>Experimental group</arm_group_label>
    <other_name>Two years basic life support training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children from 10 to 12 years old that are attending to the selected school at the&#xD;
             moment of the intervention&#xD;
&#xD;
          -  Children with signed consent given by parents at the moment of the intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children not attending all the theorical and practical interventions&#xD;
&#xD;
          -  Children not completing all test.&#xD;
&#xD;
          -  Children with learning disabilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cristina Genzor Ríos</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Semeraro F, Wingen S, Schroeder DC, Ecker H, Scapigliati A, Ristagno G, Cimpoesu D, Bottiger BW. KIDS SAVE LIVES-Three years of implementation in Europe. Resuscitation. 2018 Oct;131:e9-e11. doi: 10.1016/j.resuscitation.2018.08.008. Epub 2018 Aug 8. No abstract available.</citation>
    <PMID>30098386</PMID>
  </results_reference>
  <results_reference>
    <citation>Bottiger BW, Van Aken H. Kids save lives--Training school children in cardiopulmonary resuscitation worldwide is now endorsed by the World Health Organization (WHO). Resuscitation. 2015 Sep;94:A5-7. doi: 10.1016/j.resuscitation.2015.07.005. Epub 2015 Jul 21. No abstract available.</citation>
    <PMID>26209417</PMID>
  </results_reference>
  <results_reference>
    <citation>Bohn A, Van Aken HK, Mollhoff T, Wienzek H, Kimmeyer P, Wild E, Dopker S, Lukas RP, Weber TP. Teaching resuscitation in schools: annual tuition by trained teachers is effective starting at age 10. A four-year prospective cohort study. Resuscitation. 2012 May;83(5):619-25. doi: 10.1016/j.resuscitation.2012.01.020. Epub 2012 Jan 28.</citation>
    <PMID>22286049</PMID>
  </results_reference>
  <results_reference>
    <citation>Lukas RP, Van Aken H, Molhoff T, Weber T, Rammert M, Wild E, Bohn A. Kids save lives: a six-year longitudinal study of schoolchildren learning cardiopulmonary resuscitation: Who should do the teaching and will the effects last? Resuscitation. 2016 Apr;101:35-40. doi: 10.1016/j.resuscitation.2016.01.028. Epub 2016 Feb 8.</citation>
    <PMID>26868079</PMID>
  </results_reference>
  <results_reference>
    <citation>Bohn A, Lukas RP, Breckwoldt J, Bottiger BW, Van Aken H. 'Kids save lives': why schoolchildren should train in cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):220-5. doi: 10.1097/MCC.0000000000000204.</citation>
    <PMID>25922895</PMID>
  </results_reference>
  <results_reference>
    <citation>Haseneder R, Skrzypczak M, Haller B, Beckers SK, Holch J, Wank C, Kochs E, Schulz CM. Impact of instructor professional background and interim retesting on knowledge and self-confidence of schoolchildren after basic life support training: a cluster randomised longitudinal study. Emerg Med J. 2019 Apr;36(4):239-244. doi: 10.1136/emermed-2018-207923. Epub 2019 Feb 16.</citation>
    <PMID>30772830</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Investigación Sanitaria Aragón</investigator_affiliation>
    <investigator_full_name>Cristina Genzor</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 20, 2021</submitted>
    <returned>September 16, 2021</returned>
    <submitted>August 4, 2022</submitted>
    <returned>June 30, 2023</returned>
  </pending_results>
  <!-- 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/NCT04440111
org study id: PI19/490
nct id: NCT04440111
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A controlled clinical trial will be performed.

      School children from the age of 10 to 11 will be selected to learn basic life support (BLS)
      in a primary school of Zaragoza.

      One of the groups will learn BLS in two consecutive years and the other group will learn BLS
      only the first year.

      The investigators think that the knowledge will be better in the group that receives two
      interventions.
A controlled clinical trial will be performed.

      72 participants between 10 and 11 years old will be selected and randomized to participate.

      Control group and experimental group will enrolled 36 participants each one. Control group
      will receive BLS training once. Experimental group will receive BLS training in two
      consecutive years.

      Previous and after training a test will be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: To evaluate the knowledge level of BLS after receiving one or two interventions
time frame: 3 hours
description: A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015.
measure: To compare test results obtained previous and after intervention.
time frame: 1 month
description: A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015. After obteining the marks, the results will be compared using Statistical Analysis Software.
arm group label: Control group
arm group type: Active Comparator
description: One year basic life support training
arm group label: Experimental group
arm group type: Sham Comparator
description: Two years basic life support training
intervention type: Other
intervention name: One year training
description: At first, children will make a test to evaluate their pre- intervention basic support life knowledge.
Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015.
After that, they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will only make the test, they won't receive any theory or practice.
arm group label: Control group
other name: One year basic life support training
intervention type: Other
intervention name: Two years training
description: At first, children will make a test to evaluate their pre- intervention basic support life knowledge.
Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that they will make a practical workshop on BLS.
Finally they will repeat the initial test. The second year, this group will repeat the same process.
arm group label: Experimental group
other name: Two years basic life support training
criteria: 
gender: All
minimum age: 10 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
citation: Semeraro F, Wingen S, Schroeder DC, Ecker H, Scapigliati A, Ristagno G, Cimpoesu D, Bottiger BW. KIDS SAVE LIVES-Three years of implementation in Europe. Resuscitation. 2018 Oct;131:e9-e11. doi: 10.1016/j.resuscitation.2018.08.008. Epub 2018 Aug 8. No abstract available.
PMID: 30098386
citation: Bottiger BW, Van Aken H. Kids save lives--Training school children in cardiopulmonary resuscitation worldwide is now endorsed by the World Health Organization (WHO). Resuscitation. 2015 Sep;94:A5-7. doi: 10.1016/j.resuscitation.2015.07.005. Epub 2015 Jul 21. No abstract available.
PMID: 26209417
citation: Bohn A, Van Aken HK, Mollhoff T, Wienzek H, Kimmeyer P, Wild E, Dopker S, Lukas RP, Weber TP. Teaching resuscitation in schools: annual tuition by trained teachers is effective starting at age 10. A four-year prospective cohort study. Resuscitation. 2012 May;83(5):619-25. doi: 10.1016/j.resuscitation.2012.01.020. Epub 2012 Jan 28.
PMID: 22286049
citation: Lukas RP, Van Aken H, Molhoff T, Weber T, Rammert M, Wild E, Bohn A. Kids save lives: a six-year longitudinal study of schoolchildren learning cardiopulmonary resuscitation: Who should do the teaching and will the effects last? Resuscitation. 2016 Apr;101:35-40. doi: 10.1016/j.resuscitation.2016.01.028. Epub 2016 Feb 8.
PMID: 26868079
citation: Bohn A, Lukas RP, Breckwoldt J, Bottiger BW, Van Aken H. 'Kids save lives': why schoolchildren should train in cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):220-5. doi: 10.1097/MCC.0000000000000204.
PMID: 25922895
citation: Haseneder R, Skrzypczak M, Haller B, Beckers SK, Holch J, Wank C, Kochs E, Schulz CM. Impact of instructor professional background and interim retesting on knowledge and self-confidence of schoolchildren after basic life support training: a cluster randomised longitudinal study. Emerg Med J. 2019 Apr;36(4):239-244. doi: 10.1136/emermed-2018-207923. Epub 2019 Feb 16.
PMID: 30772830
responsible party type: Sponsor-Investigator
investigator affiliation: Instituto de Investigación Sanitaria Aragón
investigator full name: Cristina Genzor
investigator title: Principal Investigator
mesh term: Heart Arrest
sharing ipd: No
submitted: August 20, 2021
returned: September 16, 2021
submitted: August 4, 2022
returned: June 30, 2023