<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/NCT02192268</url>
  </required_header>
  <id_info>
    <org_study_id>PEP/HFOO</org_study_id>
    <nct_id>NCT02192268</nct_id>
  </id_info>
  <brief_title>Assesment of the Effectiveness of High Frequency Oral Oscillation and Mask of PEP in Children With Pneumonia</brief_title>
  <acronym>PEP/HFOO</acronym>
  <official_title>ASSESSMENT OF THE EFFECTIVENESS OF HIGH FREQUENCY ORAL OSCILLATION AND MASK OF PEP IN CHILDREN WITH PNEUMONIA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Sirio-Libanes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital e maternidade São Luiz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Sirio-Libanes</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis of this study is that the physiologic effects of these (PEP/ HFOO) resources&#xD;
      may have positive effects in this population of children with acute respiratory illness.&#xD;
&#xD;
      Thinking about this physical and physiological issue and due to the absence of a study that&#xD;
      has evaluated the effectiveness of these instruments in patients with pneumonia, the&#xD;
      objective of this study is to evaluate the short-term effects OOAF and mask of EPAP in&#xD;
      children hospitalized for community-acquired pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pneumonia is characterized by an acute infectious and inflammatory process, usually&#xD;
      compromises the alveoli, bronchioles and interstitial space difficulting hematosis and may be&#xD;
      in some or all of the cells filled with liquid and blood cells. The accumulation of secretion&#xD;
      occurs as a consequence of this infectious and inflammatory process and contributes to&#xD;
      clinical worsening by increasing airway resistance.&#xD;
&#xD;
      Respiratory physiotherapy has been questioned in patients with pneumonia and recent clinical&#xD;
      studies have shown that there is no benefit to these patients. Respiratory physical therapy&#xD;
      in addition to manual techniques has in his repertoire instrumental resources such as&#xD;
      therapeutic high-frequency oral oscillator (HFOO) and the mask of expiratory positive&#xD;
      pressure (PEP). The hypothesis of this study is that physical and physiological effects of&#xD;
      these resources may have positive effects in this population of children with acute&#xD;
      respiratory illness. The aim of this study is to evaluate the short-term effects HFOO and&#xD;
      mask of PEP in children hospitalized for community-acquired pneumonia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 1, 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Severity Score</measure>
    <time_frame>Change from Baseline Severity score at 4 days</time_frame>
    <description>Will be assigned a severity score proposed based on other studies with clinical variables and diagnostic criteria. This score will vary from 0 to 18 points. Participants will be followed for the duration of hospital stay, an expected average of 4 or 5 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Flow meter</measure>
    <time_frame>Change from Baseline peak flow at 4 days</time_frame>
    <description>Peak Flow will be held three measurements in standing position with nasal clip with MedicateTM equipment with ATS range (60 to 900lmin) adult and pediatric use. Participants will be followed for the duration of hospital stay, an expected average of 4 or 5 days.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>HFOO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children of the HFOO group will be subjected to two daily sessions of this resource which should be the same throughout her hospitalization with Shaker equipment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assisted Coughing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The children in the control group will be subjected to two daily sessions of assisted coughing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The children will be subjected to PEP group two daily sessions of this resource which should be the same throughout her hospitalization with facial mask and valve Spring load with expiratory pressure of 10cmH2O.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEP</intervention_name>
    <arm_group_label>PEP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HFOO</intervention_name>
    <arm_group_label>HFOO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assisted Coughing</intervention_name>
    <arm_group_label>Assisted Coughing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 03 and 11 years old;&#xD;
&#xD;
          -  have Pneumonia diagnosis done by a physician pediatrician (1) presence of cough and/or&#xD;
             fever; (2) tachypnea according to age group (1-5 years-40 bpm; 5 years -30 bpm); (3)&#xD;
             radiological change with consolidation or infiltrators associated or not with other&#xD;
             findings compatible with pneumonia. All films will be evaluated by a radiologist and a&#xD;
             pediatrician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic neurological Disease, or respiratory arrest&#xD;
&#xD;
          -  failure to collaborate with therapy or assessment&#xD;
&#xD;
          -  need of invasive or non-invasive ventilatory assistance&#xD;
&#xD;
          -  hemodynamic instability&#xD;
&#xD;
          -  vomiting or nausea&#xD;
&#xD;
          -  not drained Pneumothorax&#xD;
&#xD;
          -  not drained extensive pleural effusion&#xD;
&#xD;
          -  dyspnea&#xD;
&#xD;
          -  do not agree with research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evelim FD Gomes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nove de Julho</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Evelim LFD Gomes, PhD</last_name>
    <phone>551136242572</phone>
    <email>evelimfreitas@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital são Luiz Jabaquara</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Evelim FD Gomes, PhD</last_name>
      <phone>551136242572</phone>
    </contact>
    <investigator>
      <last_name>Evelim FD Gomes, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>February 22, 2017</last_update_submitted>
  <last_update_submitted_qc>February 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Sirio-Libanes</investigator_affiliation>
    <investigator_full_name>Evelim Leal de Freitas Dantas Gomes, PhD</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</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/NCT02192268
org study id: PEP/HFOO
nct id: NCT02192268
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The hypothesis of this study is that the physiologic effects of these (PEP/ HFOO) resources
      may have positive effects in this population of children with acute respiratory illness.

      Thinking about this physical and physiological issue and due to the absence of a study that
      has evaluated the effectiveness of these instruments in patients with pneumonia, the
      objective of this study is to evaluate the short-term effects OOAF and mask of EPAP in
      children hospitalized for community-acquired pneumonia.
The pneumonia is characterized by an acute infectious and inflammatory process, usually
      compromises the alveoli, bronchioles and interstitial space difficulting hematosis and may be
      in some or all of the cells filled with liquid and blood cells. The accumulation of secretion
      occurs as a consequence of this infectious and inflammatory process and contributes to
      clinical worsening by increasing airway resistance.

      Respiratory physiotherapy has been questioned in patients with pneumonia and recent clinical
      studies have shown that there is no benefit to these patients. Respiratory physical therapy
      in addition to manual techniques has in his repertoire instrumental resources such as
      therapeutic high-frequency oral oscillator (HFOO) and the mask of expiratory positive
      pressure (PEP). The hypothesis of this study is that physical and physiological effects of
      these resources may have positive effects in this population of children with acute
      respiratory illness. The aim of this study is to evaluate the short-term effects HFOO and
      mask of PEP in children hospitalized for community-acquired pneumonia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Severity Score
time frame: Change from Baseline Severity score at 4 days
description: Will be assigned a severity score proposed based on other studies with clinical variables and diagnostic criteria. This score will vary from 0 to 18 points. Participants will be followed for the duration of hospital stay, an expected average of 4 or 5 days.
measure: Change in Peak Flow meter
time frame: Change from Baseline peak flow at 4 days
description: Peak Flow will be held three measurements in standing position with nasal clip with MedicateTM equipment with ATS range (60 to 900lmin) adult and pediatric use. Participants will be followed for the duration of hospital stay, an expected average of 4 or 5 days.
arm group label: HFOO
arm group type: Active Comparator
description: Children of the HFOO group will be subjected to two daily sessions of this resource which should be the same throughout her hospitalization with Shaker equipment.
arm group label: Assisted Coughing
arm group type: Active Comparator
description: The children in the control group will be subjected to two daily sessions of assisted coughing.
arm group label: PEP
arm group type: Active Comparator
description: The children will be subjected to PEP group two daily sessions of this resource which should be the same throughout her hospitalization with facial mask and valve Spring load with expiratory pressure of 10cmH2O.
intervention type: Other
intervention name: PEP
arm group label: PEP
intervention type: Other
intervention name: HFOO
arm group label: HFOO
intervention type: Other
intervention name: Assisted Coughing
arm group label: Assisted Coughing
criteria: 
gender: All
minimum age: 3 Years
maximum age: 11 Years
healthy volunteers: No
last name: Evelim FD Gomes, PhD
role: Principal Investigator
affiliation: University of Nove de Julho
last name: Evelim LFD Gomes, PhD
phone: 551136242572
email: evelimfreitas@hotmail.com
facility: 
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Sirio-Libanes
investigator full name: Evelim Leal de Freitas Dantas Gomes, PhD
investigator title: PhD
mesh term: Pneumonia