<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/NCT03015051</url>
  </required_header>
  <id_info>
    <org_study_id>High flow RCT</org_study_id>
    <nct_id>NCT03015051</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis</brief_title>
  <official_title>Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Burlo Garofolo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Burlo Garofolo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bronchiolitis is the most common respiratory infection of the lower respiratory tract that&#xD;
      affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with&#xD;
      bronchiolitis require hospital admission because of poor feeding and/or breathing&#xD;
      difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and&#xD;
      hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of&#xD;
      the techniques of administration of oxygen in bronchiolitis is represented by the high flow&#xD;
      (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC&#xD;
      provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces&#xD;
      breathing load and allows for better nutrition. The main aim of therapy with high flows is to&#xD;
      reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have&#xD;
      been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this&#xD;
      topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot&#xD;
      study of 19 subjects comparing HFNC with oxygen administered via &quot;head box&quot;. The oxygen&#xD;
      saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs&#xD;
      96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available&#xD;
      evidence is insufficient to determine the effectiveness of HFNC.&#xD;
&#xD;
      The aim of this study is to evaluate in a large number of cases the effectiveness of&#xD;
      treatment with high flow versus standard treatment, in children with bronchiolitis referred&#xD;
      to a Pediatric Emergency Department.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty in recruiting subjects who meet the inclusion/exclusion criteria&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hours of oxygen therapy</measure>
    <time_frame>up to 5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subject admitted in intensive care unit</measure>
    <time_frame>up to 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients needing intubation</measure>
    <time_frame>up to 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of parenteral hydration or nasogastric enteral feeding</measure>
    <time_frame>up to 5 days</time_frame>
    <description>Number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>up to 15 days</time_frame>
    <description>Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>High flow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High flow (2 L/kg/min) nasal cannula oxygen therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low flow</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low flow (max 3 L/min) oxygen therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <arm_group_label>High flow</arm_group_label>
    <arm_group_label>Low flow</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of bronchiolitis&#xD;
&#xD;
          -  age &gt;28 days and &lt;6 months&#xD;
&#xD;
          -  Oxygen saturation (SaO2) &lt;92%&#xD;
&#xD;
          -  respiratory rate &gt;60 breaths/min&#xD;
&#xD;
          -  dyspnea with respiratory distress assessment instrument (RDAI) score ≥8&#xD;
&#xD;
          -  daily milk or food intake less than 2/3 than normally assumed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic diseases or syndromes&#xD;
&#xD;
          -  respiratory diseases (i.e. bronchopulmonary dysplasia)&#xD;
&#xD;
          -  heart diseases&#xD;
&#xD;
          -  preterm birth (before 36 weeks of gestational age)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Egidio Barbi, MD</last_name>
    <role>Study Chair</role>
    <affiliation>IRCCS Burlo Garofolo, Trieste, Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefania Norbedo, MD</last_name>
    <role>Study Director</role>
    <affiliation>IRCCS Burlo Garofolo, Trieste, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedale Maggiore</name>
      <address>
        <city>Bologna</city>
        <state>Emilia Romagna</state>
        <zip>40133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Morgagni-Pierantoni</name>
      <address>
        <city>Forlì</city>
        <state>Emilia Romagna</state>
        <zip>47100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Ravenna AUSL Romagna</name>
      <address>
        <city>Ravenna</city>
        <state>Emilia Romagna</state>
        <zip>48100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria degli Angeli</name>
      <address>
        <city>Pordenone</city>
        <state>Friuli Venezia Giulia</state>
        <zip>33170</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Emergency Department, IRCCS Burlo Garofolo</name>
      <address>
        <city>Trieste</city>
        <state>Friuli Venezia Giulia</state>
        <zip>34137</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Pediatrico IRCCS Bambino Gesú</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto G. Gaslini</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16120</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione MBBM c/o Ospedale San Gerardo</name>
      <address>
        <city>Monza</city>
        <state>Lombardia</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Provinciale di Macerata</name>
      <address>
        <city>Macerata</city>
        <state>Marche</state>
        <zip>62100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Principe di Piemonte Area Vasta 2</name>
      <address>
        <city>Senigallia</city>
        <state>Marche</state>
        <zip>60019</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale A. Cardarelli</name>
      <address>
        <city>Campobasso</city>
        <state>Molise</state>
        <zip>86170</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Infantile Regina Margherita</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Castelli</name>
      <address>
        <city>Verbania</city>
        <state>Piemonte</state>
        <zip>28992</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Giovanni Paolo II</name>
      <address>
        <city>Olbia</city>
        <state>Sardegna</state>
        <zip>07026</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Burlo Garofolo</investigator_affiliation>
    <investigator_full_name>Luca Ronfani</investigator_full_name>
    <investigator_title>Head of Clinical Epidemiology and Public Health Research Unit</investigator_title>
  </responsible_party>
  <keyword>Bronchiolitis</keyword>
  <keyword>High flow nasal cannula</keyword>
  <keyword>Oxygen therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</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/NCT03015051
org study id: High flow RCT
nct id: NCT03015051
lead sponsor: 
has dmc: No
Bronchiolitis is the most common respiratory infection of the lower respiratory tract that
      affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with
      bronchiolitis require hospital admission because of poor feeding and/or breathing
      difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and
      hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of
      the techniques of administration of oxygen in bronchiolitis is represented by the high flow
      (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC
      provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces
      breathing load and allows for better nutrition. The main aim of therapy with high flows is to
      reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have
      been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this
      topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot
      study of 19 subjects comparing HFNC with oxygen administered via "head box". The oxygen
      saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs
      96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available
      evidence is insufficient to determine the effectiveness of HFNC.

      The aim of this study is to evaluate in a large number of cases the effectiveness of
      treatment with high flow versus standard treatment, in children with bronchiolitis referred
      to a Pediatric Emergency Department.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hours of oxygen therapy
time frame: up to 5 days
measure: Number of subject admitted in intensive care unit
time frame: up to 5 days
measure: Number of patients needing intubation
time frame: up to 5 days
measure: Days of parenteral hydration or nasogastric enteral feeding
time frame: up to 5 days
description: Number of days
measure: Adverse events
time frame: up to 15 days
description: Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated
arm group label: High flow
arm group type: Experimental
description: High flow (2 L/kg/min) nasal cannula oxygen therapy
arm group label: Low flow
arm group type: Active Comparator
description: Low flow (max 3 L/min) oxygen therapy
intervention type: Drug
intervention name: Oxygen
arm group label: High flow
arm group label: Low flow
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: Egidio Barbi, MD
role: Study Chair
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
last name: Stefania Norbedo, MD
role: Study Director
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Burlo Garofolo
investigator full name: Luca Ronfani
investigator title: Head of Clinical Epidemiology and Public Health Research Unit
mesh term: Bronchiolitis
sharing ipd: Undecided