<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/NCT03017664</url>
  </required_header>
  <id_info>
    <org_study_id>16.04.US.HCN</org_study_id>
    <nct_id>NCT03017664</nct_id>
  </id_info>
  <brief_title>Improvement Project To Optimizing Nutrition With Higher Protein and Calorie Pediatric Tube Feeding</brief_title>
  <official_title>An Improvement Project Towards Optimizing Nutrition Intervention With a Higher Protein and Calorie Pediatric Tube Feeding Formula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This quality improvement project will include a practice change based on national guidelines&#xD;
      for the nutritional management of PICU patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This quality improvement project will include a practice change based on national guidelines&#xD;
      for the nutritional management of PICU patients. The primary aim of this quality improvement&#xD;
      project is to better meet protein needs of ICU critically ill children&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Enteral formula volume</measure>
    <time_frame>5 days</time_frame>
    <description>Daily total formula volume (mL) delivered</description>
  </primary_outcome>
  <other_outcome>
    <measure>Protein modular</measure>
    <time_frame>5 days</time_frame>
    <description>yes/no; if yes, dose (g/mL) and schedule</description>
  </other_outcome>
  <other_outcome>
    <measure>Enteral feeding interruptions</measure>
    <time_frame>5 days</time_frame>
    <description>yes/no; if yes, reason for interruption</description>
  </other_outcome>
  <other_outcome>
    <measure>Diarrhea</measure>
    <time_frame>5 days</time_frame>
    <description>yes/no; if yes, frequency in 24 hour period</description>
  </other_outcome>
  <other_outcome>
    <measure>Vomiting</measure>
    <time_frame>5 days</time_frame>
    <description>yes/no; if yes, frequency in 24 hour period</description>
  </other_outcome>
  <other_outcome>
    <measure>Elevated gastric residuals</measure>
    <time_frame>5 days</time_frame>
    <description>yes/no; if yes, amount (mL) in 24 hour period</description>
  </other_outcome>
  <other_outcome>
    <measure>Abdominal distention/pain</measure>
    <time_frame>5 days</time_frame>
    <description>yes/no</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Critically Ill Children</condition>
  <arm_group>
    <arm_group_label>RFG</arm_group_label>
    <description>Retrospective review of enteral feeding in pediatric ICU patients for up to 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PFG</arm_group_label>
    <description>Pediatric ICU population to be fed a peptide-based enteral formula with higher protein and higher calories for up to 5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peptide-based enteral formula</intervention_name>
    <description>Peptide-based, higher protein and higher calorie enteral formula</description>
    <arm_group_label>PFG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retrospective review of enteral tube feeding formula</intervention_name>
    <description>Enteral formula tube feeding will be retrospectively reviewed</description>
    <arm_group_label>RFG</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children aged 1-13 years with enteral feeding access&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 1-18 years old with enteral feeding access and anticipated to be fed for&#xD;
             5 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Krysmaru B AraujoTorres, MD</last_name>
    <role>Study Director</role>
    <affiliation>Société des Produits Nestlé (SPN)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Chicago, Comer Children's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Bonheur Children's Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 23, 2020</last_update_submitted>
  <last_update_submitted_qc>January 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</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>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03017664
org study id: 16.04.US.HCN
nct id: NCT03017664
lead sponsor: 
has dmc: No
This quality improvement project will include a practice change based on national guidelines
      for the nutritional management of PICU patients.
This quality improvement project will include a practice change based on national guidelines
      for the nutritional management of PICU patients. The primary aim of this quality improvement
      project is to better meet protein needs of ICU critically ill children
observational model: Cohort
time perspective: Prospective
measure: Enteral formula volume
time frame: 5 days
description: Daily total formula volume (mL) delivered
measure: Protein modular
time frame: 5 days
description: yes/no; if yes, dose (g/mL) and schedule
measure: Enteral feeding interruptions
time frame: 5 days
description: yes/no; if yes, reason for interruption
measure: Diarrhea
time frame: 5 days
description: yes/no; if yes, frequency in 24 hour period
measure: Vomiting
time frame: 5 days
description: yes/no; if yes, frequency in 24 hour period
measure: Elevated gastric residuals
time frame: 5 days
description: yes/no; if yes, amount (mL) in 24 hour period
measure: Abdominal distention/pain
time frame: 5 days
description: yes/no
arm group label: RFG
description: Retrospective review of enteral feeding in pediatric ICU patients for up to 5 days
arm group label: PFG
description: Pediatric ICU population to be fed a peptide-based enteral formula with higher protein and higher calories for up to 5 days
intervention type: Other
intervention name: Peptide-based enteral formula
description: Peptide-based, higher protein and higher calorie enteral formula
arm group label: PFG
intervention type: Other
intervention name: Retrospective review of enteral tube feeding formula
description: Enteral formula tube feeding will be retrospectively reviewed
arm group label: RFG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 13 Years
healthy volunteers: No
last name: Krysmaru B AraujoTorres, MD
role: Study Director
affiliation: Société des Produits Nestlé (SPN)
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: No