<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/NCT03824249</url>
  </required_header>
  <id_info>
    <org_study_id>2019/834</org_study_id>
    <nct_id>NCT03824249</nct_id>
  </id_info>
  <brief_title>Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation</brief_title>
  <acronym>CALO-NIV</acronym>
  <official_title>Validation of Energy Expenditure Measurement With Indirect Calorimetry in Pediatric Patients Undergoing Non-invasive Ventilation Through a Single-limb Circuit With Intentional Leak: a Single Center, Cross-over, Non Pharmacological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</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>
      Nutritional status in critically ill pediatric patients is considered a fundamental&#xD;
      prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies&#xD;
      report how predictive equations most commonly applied are inaccurate, therefore under or over&#xD;
      estimating the body energy requirements. For this reason, actual measurement of resting&#xD;
      energy expenditure (REE) through indirect calorimetry (IC) is considered to be a better&#xD;
      approach.&#xD;
&#xD;
      Currently, IC is not validated during the use of non-invasive ventilation.&#xD;
&#xD;
      Aim of the present study is to validate the measurement of REE with IC in pediatric patients&#xD;
      undergoing non-invasive ventilation through a single-limb circuit with intentional leak.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2019</start_date>
  <completion_date type="Actual">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">February 15, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resting energy expenditure (REE)</measure>
    <time_frame>1 day</time_frame>
    <description>Resting energy expenditure expressed in kcal/kg/die</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Carbon dioxide production (VCO2)</measure>
    <time_frame>1 day</time_frame>
    <description>Quantity of carbon dioxide exhaled by the patients [expressed in ml/kg/min]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen consumption (VO2)</measure>
    <time_frame>1 day</time_frame>
    <description>Quantity of oxygen consumed by the patients [expressed in ml/kg/min]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory quotient (RQ)</measure>
    <time_frame>1 day</time_frame>
    <description>Respiratory quotient [expressed as VCO2/VO2]</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Respiratory Insufficiency in Children</condition>
  <condition>Noninvasive Ventilation</condition>
  <condition>Nutrition Assessment</condition>
  <arm_group>
    <arm_group_label>Spontaneous breathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Performance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIV-CPAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Performance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 centimeters of water (cmH2O). CPAP will be applied via single-limb circuit with intentional leak.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIV-PS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Performance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 cmH2O and Pressure support (PS) of 8 cmH2O. Non-invasive ventilation will be applied via single-limb circuit with intentional leak.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Indirect Calorimetry</intervention_name>
    <description>Performance of indirect calorimetry in Canopy mode.</description>
    <arm_group_label>NIV-CPAP</arm_group_label>
    <arm_group_label>NIV-PS</arm_group_label>
    <arm_group_label>Spontaneous breathing</arm_group_label>
    <other_name>IC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children admitted to the Pediatric Intensive Care Unit who completed the weaning phase&#xD;
             from non-invasive ventilation.&#xD;
&#xD;
          -  age ≤ 6 years&#xD;
&#xD;
          -  patients whose parents provided signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt; 6 years&#xD;
&#xD;
          -  patients whose parents didn't provide signed informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Langer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edoardo Calderini, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlo Agostoni, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Energy Expenditure</keyword>
  <keyword>Ventilator Weaning</keyword>
  <keyword>Calorimetry, indirect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT03824249
org study id: 2019/834
nct id: NCT03824249
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nutritional status in critically ill pediatric patients is considered a fundamental
      prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies
      report how predictive equations most commonly applied are inaccurate, therefore under or over
      estimating the body energy requirements. For this reason, actual measurement of resting
      energy expenditure (REE) through indirect calorimetry (IC) is considered to be a better
      approach.

      Currently, IC is not validated during the use of non-invasive ventilation.

      Aim of the present study is to validate the measurement of REE with IC in pediatric patients
      undergoing non-invasive ventilation through a single-limb circuit with intentional leak.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Resting energy expenditure (REE)
time frame: 1 day
description: Resting energy expenditure expressed in kcal/kg/die
measure: Carbon dioxide production (VCO2)
time frame: 1 day
description: Quantity of carbon dioxide exhaled by the patients [expressed in ml/kg/min]
measure: Oxygen consumption (VO2)
time frame: 1 day
description: Quantity of oxygen consumed by the patients [expressed in ml/kg/min]
measure: Respiratory quotient (RQ)
time frame: 1 day
description: Respiratory quotient [expressed as VCO2/VO2]
arm group label: Spontaneous breathing
arm group type: Experimental
description: Performance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry.
arm group label: NIV-CPAP
arm group type: Experimental
description: Performance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 centimeters of water (cmH2O). CPAP will be applied via single-limb circuit with intentional leak.
arm group label: NIV-PS
arm group type: Experimental
description: Performance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 cmH2O and Pressure support (PS) of 8 cmH2O. Non-invasive ventilation will be applied via single-limb circuit with intentional leak.
intervention type: Diagnostic Test
intervention name: Indirect Calorimetry
description: Performance of indirect calorimetry in Canopy mode.
arm group label: NIV-CPAP
arm group label: NIV-PS
arm group label: Spontaneous breathing
other name: IC
criteria: 
gender: All
minimum age: 1 Month
maximum age: 6 Years
healthy volunteers: No
last name: Thomas Langer, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
last name: Edoardo Calderini, MD
role: Study Chair
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
last name: Carlo Agostoni, MD
role: Study Chair
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Respiratory Insufficiency