<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/NCT01714076</url>
  </required_header>
  <id_info>
    <org_study_id>JB-3</org_study_id>
    <nct_id>NCT01714076</nct_id>
  </id_info>
  <brief_title>Co-infections in Children Hospitalised for Bronchiolitis</brief_title>
  <official_title>Co-infections in Children Hospitalised for Bronchiolitis: Incidence, Clinical Symptoms and Influence of Cohort Isolation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Princess Amalia Children's Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Princess Amalia Children's Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational cohort study in children hospitalized for acute bronchiolitis. Patients are&#xD;
      nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of&#xD;
      co-infections in this group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational cohort study in children hospitalized for acute bronchiolitis. Patients are&#xD;
      nursed in cohort isolation, meaning that all patients admitted for bronchiolitis are cohorted&#xD;
      together, irrespective of viral diagnosis. Aim is to investigate the incidence and clinical&#xD;
      impact of co-infections in this group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>co-infection</measure>
    <time_frame>approximately 2 weeks</time_frame>
    <description>co-infection acquired during hospitalisation, patient will be followed during hospitalisation and until 1 week after discharge from the hospital, since average duration of hospitalisation in infants with bronchiolitis is 3 days, the time frame will be approximately 2 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical severity</measure>
    <time_frame>approximately 2 weeks</time_frame>
    <description>clinical severity defined as, days of oxygen supplementation, tube feeding, dyspnea score, length of hospitalisation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">172</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>cohort isolation</arm_group_label>
    <description>patients with bronchiolitis are cohorted together irrespective of viral agent diagnosed, thus respiratory syncytial virus (RSV)-positive patient stay in the same room as RSV-negative patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cohort isolation</intervention_name>
    <description>all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis</description>
    <arm_group_label>cohort isolation</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      sputum tested for viral agents by PCR-techniques&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        children &lt; 2 years admitted for bronchiolitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  younger than 2 years admitted for bronchiolitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic lung disease congenital heart defect down syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jolita Bekhof, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Isala</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Isala Klinieken</name>
      <address>
        <city>Zwolle</city>
        <state>Overijssel</state>
        <zip>8000 GK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>October 21, 2015</last_update_submitted>
  <last_update_submitted_qc>October 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Princess Amalia Children's Clinic</investigator_affiliation>
    <investigator_full_name>Jolita Bekhof</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Coinfection</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/NCT01714076
org study id: JB-3
nct id: NCT01714076
lead sponsor: 
has dmc: No
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are
      nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of
      co-infections in this group.
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are
      nursed in cohort isolation, meaning that all patients admitted for bronchiolitis are cohorted
      together, irrespective of viral diagnosis. Aim is to investigate the incidence and clinical
      impact of co-infections in this group.
observational model: Cohort
time perspective: Prospective
measure: co-infection
time frame: approximately 2 weeks
description: co-infection acquired during hospitalisation, patient will be followed during hospitalisation and until 1 week after discharge from the hospital, since average duration of hospitalisation in infants with bronchiolitis is 3 days, the time frame will be approximately 2 weeks
measure: clinical severity
time frame: approximately 2 weeks
description: clinical severity defined as, days of oxygen supplementation, tube feeding, dyspnea score, length of hospitalisation
arm group label: cohort isolation
description: patients with bronchiolitis are cohorted together irrespective of viral agent diagnosed, thus respiratory syncytial virus (RSV)-positive patient stay in the same room as RSV-negative patients
intervention type: Other
intervention name: cohort isolation
description: all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis
arm group label: cohort isolation
sputum tested for viral agents by PCR-techniques
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 24 Months
healthy volunteers: No
last name: Jolita Bekhof, MD
role: Principal Investigator
affiliation: Isala
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Princess Amalia Children's Clinic
investigator full name: Jolita Bekhof
investigator title: MD
mesh term: Bronchiolitis
mesh term: Coinfection