<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/NCT01684527</url>
  </required_header>
  <id_info>
    <org_study_id>0039-12-HYMC</org_study_id>
    <nct_id>NCT01684527</nct_id>
  </id_info>
  <brief_title>Immature Myeloid Cells in Respiratory Syncytial Virus Bronchioliltis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence&#xD;
      the population of lung immature myeloid cells and dendritic cells in a way that will impair&#xD;
      their ability to invoke an effective immune response and lead to prolonged inflammation,&#xD;
      angiogenesis and scarring. This may lead in turn to disturbed lung function.&#xD;
&#xD;
      Our aim is to determine the presence and phenotype of immature myeloid cells present in&#xD;
      respiratory secretions of children with RSV bronchiolitis as compared to non-RSV&#xD;
      bronchiolitis and healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">January 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Immature Myeloid Cells in Respiratory Secretions</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of one week</time_frame>
    <description>Respiratory secretions obtained from child presenting with bronchiolitis will be examined for the presence of immature myeloid cells</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>Children Suffering From Bronchiolitis</arm_group_label>
    <description>Respiratory secretions obtained from children suffering from Bronchiolitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Children</arm_group_label>
    <description>Respiratory secretions obtained from children with no respiratory infection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Respiratory secretions obtained</intervention_name>
    <arm_group_label>Children Suffering From Bronchiolitis</arm_group_label>
    <arm_group_label>Healthy Children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children presenting in our pediatric department suffering from bronchiolitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bronchiolitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Vered Nir, MD</last_name>
      <phone>972-4-630-4331</phone>
      <email>verednr@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Vered Nir, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 10, 2012</last_update_submitted>
  <last_update_submitted_qc>September 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</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/NCT01684527
org study id: 0039-12-HYMC
nct id: NCT01684527
lead sponsor: 
has dmc: Yes
The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence
      the population of lung immature myeloid cells and dendritic cells in a way that will impair
      their ability to invoke an effective immune response and lead to prolonged inflammation,
      angiogenesis and scarring. This may lead in turn to disturbed lung function.

      Our aim is to determine the presence and phenotype of immature myeloid cells present in
      respiratory secretions of children with RSV bronchiolitis as compared to non-RSV
      bronchiolitis and healthy controls.
observational model: Case-Control
time perspective: Prospective
measure: Number of Immature Myeloid Cells in Respiratory Secretions
time frame: Participants will be followed for the duration of hospital stay, an expected average of one week
description: Respiratory secretions obtained from child presenting with bronchiolitis will be examined for the presence of immature myeloid cells
arm group label: Children Suffering From Bronchiolitis
description: Respiratory secretions obtained from children suffering from Bronchiolitis
arm group label: Healthy Children
description: Respiratory secretions obtained from children with no respiratory infection
intervention type: Other
intervention name: Respiratory secretions obtained
arm group label: Children Suffering From Bronchiolitis
arm group label: Healthy Children
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Bronchiolitis