<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/NCT03803657</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00030228</org_study_id>
    <nct_id>NCT03803657</nct_id>
  </id_info>
  <brief_title>Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates</brief_title>
  <official_title>Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have created and validated a device that allows us to accurately measure&#xD;
      how many calories a baby consumes every day. The purpose of this study is to compare how many&#xD;
      calories a baby consumes with how many calories are provided in a population of newborn&#xD;
      infants and children. This may help clinicians to better understand how to feed babies during&#xD;
      times of critical illness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Never started&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 1, 2023</start_date>
  <completion_date type="Anticipated">March 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2024</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>Average caloric expenditure</measure>
    <time_frame>through study completion, an average of 3 days</time_frame>
    <description>Number of calories consumed</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Calorie Overload</condition>
  <condition>Calorie Deficiency</condition>
  <arm_group>
    <arm_group_label>Neonates</arm_group_label>
    <description>Neonates 0-28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infant</arm_group_label>
    <description>29 days to 1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child</arm_group_label>
    <description>&gt;1 year and &lt;10 kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monitoring of energy expenditure</intervention_name>
    <description>Continuous monitoring of energy expenditure.</description>
    <arm_group_label>Child</arm_group_label>
    <arm_group_label>Infant</arm_group_label>
    <arm_group_label>Neonates</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mechanically ventilated children.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg&#xD;
&#xD;
          2. Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care&#xD;
             unit&#xD;
&#xD;
          3. Assent of patient's intensive care attending physician&#xD;
&#xD;
          4. Written parental informed consent.&#xD;
&#xD;
          5. Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with&#xD;
             fraction of inspired oxygen &lt;80%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant tracheo-esophageal fistula&#xD;
&#xD;
          2. Measured ETT leak &gt;20% (i.e. difference between inspiratory and expiratory tidal&#xD;
             volumes)&#xD;
&#xD;
          3. Patient on high frequency oscillatory ventilation or high frequency jet ventilation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Nachman E, Clemensen P, Santos K, Cole AR, Polizzotti BD, Hofmann G, Leeman KT, van den Bosch SJ, Kheir JN. A Device for the Quantification of Oxygen Consumption and Caloric Expenditure in the Neonatal Range. Anesth Analg. 2018 Jul;127(1):95-104. doi: 10.1213/ANE.0000000000003308.</citation>
    <PMID>29505450</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>John Kheir</investigator_full_name>
    <investigator_title>Staff physician</investigator_title>
  </responsible_party>
  <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/NCT03803657
org study id: IRB-P00030228
nct id: NCT03803657
lead sponsor: 
has dmc: Yes
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The investigators have created and validated a device that allows us to accurately measure
      how many calories a baby consumes every day. The purpose of this study is to compare how many
      calories a baby consumes with how many calories are provided in a population of newborn
      infants and children. This may help clinicians to better understand how to feed babies during
      times of critical illness.
observational model: Cohort
time perspective: Prospective
measure: Average caloric expenditure
time frame: through study completion, an average of 3 days
description: Number of calories consumed
arm group label: Neonates
description: Neonates 0-28 days
arm group label: Infant
description: 29 days to 1 year
arm group label: Child
description: >1 year and <10 kg
intervention type: Device
intervention name: Monitoring of energy expenditure
description: Continuous monitoring of energy expenditure.
arm group label: Child
arm group label: Infant
arm group label: Neonates
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
citation: Nachman E, Clemensen P, Santos K, Cole AR, Polizzotti BD, Hofmann G, Leeman KT, van den Bosch SJ, Kheir JN. A Device for the Quantification of Oxygen Consumption and Caloric Expenditure in the Neonatal Range. Anesth Analg. 2018 Jul;127(1):95-104. doi: 10.1213/ANE.0000000000003308.
PMID: 29505450
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: John Kheir
investigator title: Staff physician
sharing ipd: Undecided