<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/NCT02973347</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-039</org_study_id>
    <nct_id>NCT02973347</nct_id>
  </id_info>
  <brief_title>Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs</brief_title>
  <official_title>Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mechanical ventilation has become one of the most important supportive treatment methods to&#xD;
      save the life of critically ill children over time. Ventilator-associated pneumonia (VAP) is&#xD;
      a common complication of mechanical ventilation. It is one of the leading causes of&#xD;
      hospital-acquired infections in the Paediatric Intensive Care Unit (PICU).VAP can aggravate&#xD;
      patients' condition and have adverse effect on mechanical ventilation. Moreover, VAP is&#xD;
      associated with significant increased mortality. In those critical ill patients, the&#xD;
      catabolism increased, the anabolism decreased, which can induce negative nitrogen balance.&#xD;
      The consensus of optimal nutrition therapy in pediatric critical care in the Asia-Pacific,&#xD;
      released in 2014, clearly recommended that early enteral nutrition support, which begin&#xD;
      within 24-48 hours after admitting in PICU, can significantly reduce the prevalence and&#xD;
      mortality of nosocomial infection. Intermittent enteral feeding and continual enteral feeding&#xD;
      are the most common methods of enteral nutrition at present. There is no final conclusion&#xD;
      about the association between enteral nutrition methods and VAP. Thus, the relationship&#xD;
      between enteral feeding and VAP has long been a controversial issue. There is little clinical&#xD;
      research on the correlation between enteral nutrition and VAP in children with mechanical&#xD;
      ventilation, and mostly were observational studies which lacks strong evidence. How to choose&#xD;
      the appropriate enteral nutrition remains an urgent need in PICU clinical work. Therefore, it&#xD;
      is necessary for us to analyze the relationship between enteral feeding and VAP in critically&#xD;
      ill children. This study would perform a two-year research with mechanical ventilated&#xD;
      patients in PICU of four children hospitals in Shanghai, which aim to determine the&#xD;
      relationship between different enteral feeding methods and VAP, to collect the baseline&#xD;
      characteristic data of ventilated children, to analyze the risk factors for VAP in PICU&#xD;
      patients. The results from our study would contribute to improving the standard of care for&#xD;
      children undergoing mechanical ventilation, reducing their lung injury and improving&#xD;
      prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the development and advancement of modern medical technology, mechanical ventilation has&#xD;
      become one of the most important supportive treatment methods to save the life of critically&#xD;
      ill children. Ventilator-associated pneumonia （VAP） is a common complication of mechanical&#xD;
      ventilation. It is one of the leading causes of hospital-acquired infections in the PICU. VAP&#xD;
      can aggravate patients' condition and have adverse effect on mechanical ventilation. An&#xD;
      overseas study reported that VAP increased 56% of the PICU length of stay and 43% of the&#xD;
      length of hospitalization. Moreover, VAP is associated with significant increased mortality.&#xD;
      Because the prevalence and mortality of VAP vary in adult and children, also in different&#xD;
      area, it is very necessary to investigate the current status of VAP in local children, which&#xD;
      can contribute to clinical prevention and treatment to decrease mortality. Appropriate&#xD;
      nutrition support can improve the body's metabolism, promote tissue and body function repair,&#xD;
      reduce the incidence of complications. However, inadequate enteral nutrition may cause&#xD;
      gastroesophageal reflux and aspiration, which may lead to VAP and exacerbate the condition.&#xD;
      Intermittent enteral feeding and continual enteral feeding are the most common methods of&#xD;
      enteral nutrition at present. The relationship between enteral feeding methods and VAP has&#xD;
      long been a controversial issue. There is little clinical research on the correlation between&#xD;
      enteral feeding and VAP in children with mechanical ventilation, and mostly were&#xD;
      observational studies which lacks strong evidence. How to choose the appropriate enteral&#xD;
      nutrition remains an urgent need in PICU clinical work. Therefore, it is necessary for us to&#xD;
      analyze the relationship between enteral feeding and VAP in critically ill children.&#xD;
&#xD;
      The primary objective of this study is to investigate the influence of intermittent or&#xD;
      continuous enteral feeding on VAP in PICUs. The secondary objectives are to collect the&#xD;
      baseline characteristic data of ventilated children, and to analyze the risk factors of VAP&#xD;
      in children. Each patient will be randomly assigned to an intermittent or continuous enteral&#xD;
      feeding schedule. Intermittent enteral feeding schedule: feed administered via the&#xD;
      nasogastric tube less than 30 mins. Continuous enteral feeding schedule: feed pump delivered&#xD;
      via the nasogastric tube over 24 hours. Data on feeding progression, respiratory status and&#xD;
      incidence of VAP will be collected and compared. The study will also collect data on baseline&#xD;
      characters, ventilation management, ventilated days and the time to discharge from the&#xD;
      hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ventilator-associated pneumonia</measure>
    <time_frame>at Day-28</time_frame>
    <description>The incidence of VAP in patients with intermittent enteral feeding strategy is compared with the incidence of VAP in patients with continuous enteral feeding strategy. Diagnosis of VAP as defined by national diagnostic criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of ICU stay</measure>
    <time_frame>at Day-28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>at Day-28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>at Day-28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>at Day-28</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Enteral Feeding</condition>
  <condition>Ventilator-Associated Pneumonia</condition>
  <arm_group>
    <arm_group_label>Intermittent enteral feeding</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intermittent enteral feeding via the nasogastric tube is applied less than 30 mins.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous enteral feeding</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous enteral feeding via the nasogastric tube using infusion pump is applied for 24 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intermittent enteral feeding</intervention_name>
    <description>The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube less than 30 mins.</description>
    <arm_group_label>Intermittent enteral feeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuous enteral feeding</intervention_name>
    <description>The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube for 24 hours.</description>
    <arm_group_label>Continuous enteral feeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 29 days to 16 years.&#xD;
&#xD;
          -  Subjects ventilated over or equal to 12 hours.&#xD;
&#xD;
          -  Endotracheal intubation.&#xD;
&#xD;
          -  Subjects without contraindication for enteral feeding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newborn or age &gt; or equal to 16 years.&#xD;
&#xD;
          -  Subjects has been ventilated before this research.&#xD;
&#xD;
          -  Subjects ventilated less than 12 hours.&#xD;
&#xD;
          -  Invasive ventilation.&#xD;
&#xD;
          -  Subjects with severe congenital malformations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>29 Days</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaodong Zhu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yueniu Zhu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yueniu Zhu, PhD</last_name>
    <phone>+86-21-25078999</phone>
    <phone_ext>8353</phone_ext>
    <email>zhuyueniu@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lingxuezi Zhang, MD</last_name>
    <phone>+86-21-25078999</phone>
    <phone_ext>8355</phone_ext>
    <email>zlxz1989@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Enteral Feeding</keyword>
  <keyword>Ventilator-Associated Pneumonia</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Pediatric Intensive Care Unit</keyword>
  <keyword>Critical Illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</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/NCT02973347
org study id: XH-16-039
nct id: NCT02973347
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Mechanical ventilation has become one of the most important supportive treatment methods to
      save the life of critically ill children over time. Ventilator-associated pneumonia (VAP) is
      a common complication of mechanical ventilation. It is one of the leading causes of
      hospital-acquired infections in the Paediatric Intensive Care Unit (PICU).VAP can aggravate
      patients' condition and have adverse effect on mechanical ventilation. Moreover, VAP is
      associated with significant increased mortality. In those critical ill patients, the
      catabolism increased, the anabolism decreased, which can induce negative nitrogen balance.
      The consensus of optimal nutrition therapy in pediatric critical care in the Asia-Pacific,
      released in 2014, clearly recommended that early enteral nutrition support, which begin
      within 24-48 hours after admitting in PICU, can significantly reduce the prevalence and
      mortality of nosocomial infection. Intermittent enteral feeding and continual enteral feeding
      are the most common methods of enteral nutrition at present. There is no final conclusion
      about the association between enteral nutrition methods and VAP. Thus, the relationship
      between enteral feeding and VAP has long been a controversial issue. There is little clinical
      research on the correlation between enteral nutrition and VAP in children with mechanical
      ventilation, and mostly were observational studies which lacks strong evidence. How to choose
      the appropriate enteral nutrition remains an urgent need in PICU clinical work. Therefore, it
      is necessary for us to analyze the relationship between enteral feeding and VAP in critically
      ill children. This study would perform a two-year research with mechanical ventilated
      patients in PICU of four children hospitals in Shanghai, which aim to determine the
      relationship between different enteral feeding methods and VAP, to collect the baseline
      characteristic data of ventilated children, to analyze the risk factors for VAP in PICU
      patients. The results from our study would contribute to improving the standard of care for
      children undergoing mechanical ventilation, reducing their lung injury and improving
      prognosis.
With the development and advancement of modern medical technology, mechanical ventilation has
      become one of the most important supportive treatment methods to save the life of critically
      ill children. Ventilator-associated pneumonia （VAP） is a common complication of mechanical
      ventilation. It is one of the leading causes of hospital-acquired infections in the PICU. VAP
      can aggravate patients' condition and have adverse effect on mechanical ventilation. An
      overseas study reported that VAP increased 56% of the PICU length of stay and 43% of the
      length of hospitalization. Moreover, VAP is associated with significant increased mortality.
      Because the prevalence and mortality of VAP vary in adult and children, also in different
      area, it is very necessary to investigate the current status of VAP in local children, which
      can contribute to clinical prevention and treatment to decrease mortality. Appropriate
      nutrition support can improve the body's metabolism, promote tissue and body function repair,
      reduce the incidence of complications. However, inadequate enteral nutrition may cause
      gastroesophageal reflux and aspiration, which may lead to VAP and exacerbate the condition.
      Intermittent enteral feeding and continual enteral feeding are the most common methods of
      enteral nutrition at present. The relationship between enteral feeding methods and VAP has
      long been a controversial issue. There is little clinical research on the correlation between
      enteral feeding and VAP in children with mechanical ventilation, and mostly were
      observational studies which lacks strong evidence. How to choose the appropriate enteral
      nutrition remains an urgent need in PICU clinical work. Therefore, it is necessary for us to
      analyze the relationship between enteral feeding and VAP in critically ill children.

      The primary objective of this study is to investigate the influence of intermittent or
      continuous enteral feeding on VAP in PICUs. The secondary objectives are to collect the
      baseline characteristic data of ventilated children, and to analyze the risk factors of VAP
      in children. Each patient will be randomly assigned to an intermittent or continuous enteral
      feeding schedule. Intermittent enteral feeding schedule: feed administered via the
      nasogastric tube less than 30 mins. Continuous enteral feeding schedule: feed pump delivered
      via the nasogastric tube over 24 hours. Data on feeding progression, respiratory status and
      incidence of VAP will be collected and compared. The study will also collect data on baseline
      characters, ventilation management, ventilated days and the time to discharge from the
      hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Ventilator-associated pneumonia
time frame: at Day-28
description: The incidence of VAP in patients with intermittent enteral feeding strategy is compared with the incidence of VAP in patients with continuous enteral feeding strategy. Diagnosis of VAP as defined by national diagnostic criteria.
measure: Duration of ICU stay
time frame: at Day-28
measure: Duration of hospital stay
time frame: at Day-28
measure: ICU mortality
time frame: at Day-28
measure: Hospital mortality
time frame: at Day-28
arm group label: Intermittent enteral feeding
arm group type: Active Comparator
description: Intermittent enteral feeding via the nasogastric tube is applied less than 30 mins.
arm group label: Continuous enteral feeding
arm group type: Active Comparator
description: Continuous enteral feeding via the nasogastric tube using infusion pump is applied for 24 hours.
intervention type: Other
intervention name: Intermittent enteral feeding
description: The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube less than 30 mins.
arm group label: Intermittent enteral feeding
intervention type: Other
intervention name: Continuous enteral feeding
description: The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube for 24 hours.
arm group label: Continuous enteral feeding
criteria: 
gender: All
minimum age: 29 Days
maximum age: 16 Years
healthy volunteers: No
last name: Xiaodong Zhu, MD
role: Principal Investigator
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
last name: Yueniu Zhu, PhD
role: Study Director
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
last name: Yueniu Zhu, PhD
phone: +86-21-25078999
phone ext: 8353
email: zhuyueniu@hotmail.com
last name: Lingxuezi Zhang, MD
phone: +86-21-25078999
phone ext: 8355
email: zlxz1989@hotmail.com
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Ventilator-Associated
sharing ipd: Undecided