<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/NCT03763695</url>
  </required_header>
  <id_info>
    <org_study_id>1855</org_study_id>
    <nct_id>NCT03763695</nct_id>
  </id_info>
  <brief_title>Effectiveness of a VAP Prevention Bundle in the PICU</brief_title>
  <official_title>Effectiveness of a Bundle of Ventilator Associated Pneumonia (VAP) Prevention in the Pediatric Intensive Care Unit (PICU): an Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ilaria Vitali</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Antonio Maria Dell Anna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Leonardo Dassatti</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Giuseppe Bello</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Giorgio Conti</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Antonio D Addona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
  <oversight_info>
    <has_dmc>No</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>
      This observational monocentric prospective study aims to evaluate the efficacy of new&#xD;
      measures for ventilator associated pneumonia (VAP) management in the pediatric population in&#xD;
      the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8&#xD;
      beds. The investigators will compare the incidence of VAP in the group of patients in which&#xD;
      this protocol has been implemented to a retrospective control group of patients before the&#xD;
      new protocol implementation. VAP bundle includes oral care hygiene measures (i.e&#xD;
      chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45&#xD;
      degrees.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>VAP incidence</measure>
    <time_frame>From 48 hours after intubation to 48 hours after extubation</time_frame>
    <description>Incidence of VAP in pediatric patients intubated for more than 48 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of orotracheal bacterial colonization in ventilated patients</measure>
    <time_frame>From 48 hours after intubation to 48 hours after extubation</time_frame>
    <description>Evaluation of orotracheal bacterial colonization in pediatric patients undergoing mechanical ventilation twice a week</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">242</enrollment>
  <condition>Ventilator Associated Pneumonia</condition>
  <arm_group>
    <arm_group_label>Retrospective control group</arm_group_label>
    <description>Patients admitted in our PICU before the implementation of the protocol for VAP prevention (from 01/01/2016 to 12/31/2017)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prospective group</arm_group_label>
    <description>Patients admitted to our PICU since the VAP bundle has been introduced in the clinical practice (from 01/01/2018)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measures for the VAP prevention in the PICU</intervention_name>
    <description>Oral hygiene care (i.e chlorhexidine swab); clean and dry ventilator circuits; head positioning at 45 degrees.</description>
    <arm_group_label>Prospective group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of VAP incidence before the protocol introduction</intervention_name>
    <description>evaluation of VAP incidence in our pediatric population of intensive care patients before the implementation of the protocol for VAP prevention</description>
    <arm_group_label>Retrospective control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients admitted to our ICU requiring mechanical ventilation for more than 48&#xD;
        hours&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  patients receiving mechanical ventilation for more than 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no informed consent&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  previous endotracheal antibiotic therapy&#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>Giorgio Conti, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Agostino Gemelli; IRCCS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Orazio Genovese, MD</last_name>
    <phone>0630153125</phone>
    <email>orazio.genovese@policlinicogemelli.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Orazio Genovese, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 1, 2018</last_update_submitted>
  <last_update_submitted_qc>December 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
    <investigator_full_name>Orazio Genovese</investigator_full_name>
    <investigator_title>Medical Doctor, pediatric intensive care unit</investigator_title>
  </responsible_party>
  <keyword>Pediatric intensive care unit</keyword>
  <keyword>Oral Hygiene Care</keyword>
  <keyword>Chlorhexidine</keyword>
  <keyword>Broncho-alveolar lavage</keyword>
  <keyword>Pharyngeal swab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03763695
org study id: 1855
nct id: NCT03763695
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational monocentric prospective study aims to evaluate the efficacy of new
      measures for ventilator associated pneumonia (VAP) management in the pediatric population in
      the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8
      beds. The investigators will compare the incidence of VAP in the group of patients in which
      this protocol has been implemented to a retrospective control group of patients before the
      new protocol implementation. VAP bundle includes oral care hygiene measures (i.e
      chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45
      degrees.
observational model: Case-Control
time perspective: Other
measure: VAP incidence
time frame: From 48 hours after intubation to 48 hours after extubation
description: Incidence of VAP in pediatric patients intubated for more than 48 hours
measure: Prevalence of orotracheal bacterial colonization in ventilated patients
time frame: From 48 hours after intubation to 48 hours after extubation
description: Evaluation of orotracheal bacterial colonization in pediatric patients undergoing mechanical ventilation twice a week
arm group label: Retrospective control group
description: Patients admitted in our PICU before the implementation of the protocol for VAP prevention (from 01/01/2016 to 12/31/2017)
arm group label: Prospective group
description: Patients admitted to our PICU since the VAP bundle has been introduced in the clinical practice (from 01/01/2018)
intervention type: Other
intervention name: Measures for the VAP prevention in the PICU
description: Oral hygiene care (i.e chlorhexidine swab); clean and dry ventilator circuits; head positioning at 45 degrees.
arm group label: Prospective group
intervention type: Other
intervention name: Evaluation of VAP incidence before the protocol introduction
description: evaluation of VAP incidence in our pediatric population of intensive care patients before the implementation of the protocol for VAP prevention
arm group label: Retrospective control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Giorgio Conti, MD
role: Study Chair
affiliation: Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Agostino Gemelli; IRCCS
last name: Orazio Genovese, MD
phone: 0630153125
email: orazio.genovese@policlinicogemelli.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
investigator full name: Orazio Genovese
investigator title: Medical Doctor, pediatric intensive care unit
mesh term: Pneumonia
mesh term: Pneumonia, Ventilator-Associated
sharing ipd: Undecided