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Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs

Primary Purpose

Enteral Feeding, Ventilator-Associated Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent enteral feeding
Continuous enteral feeding
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Enteral Feeding focused on measuring Enteral Feeding, Ventilator-Associated Pneumonia, Mechanical Ventilation, Pediatric Intensive Care Unit, Critical Illness

Eligibility Criteria

29 Days - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of 29 days to 16 years.
  • Subjects ventilated over or equal to 12 hours.
  • Endotracheal intubation.
  • Subjects without contraindication for enteral feeding.

Exclusion Criteria:

  • Newborn or age > or equal to 16 years.
  • Subjects has been ventilated before this research.
  • Subjects ventilated less than 12 hours.
  • Invasive ventilation.
  • Subjects with severe congenital malformations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Intermittent enteral feeding

    Continuous enteral feeding

    Arm Description

    Intermittent enteral feeding via the nasogastric tube is applied less than 30 mins.

    Continuous enteral feeding via the nasogastric tube using infusion pump is applied for 24 hours.

    Outcomes

    Primary Outcome Measures

    Ventilator-associated pneumonia
    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.

    Secondary Outcome Measures

    Duration of ICU stay
    Duration of hospital stay
    ICU mortality
    Hospital mortality

    Full Information

    First Posted
    November 22, 2016
    Last Updated
    November 22, 2016
    Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    Collaborators
    Children's Hospital of Fudan University, Shanghai Children's Hospital, Shanghai Children's Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02973347
    Brief Title
    Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs
    Official Title
    Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    Collaborators
    Children's Hospital of Fudan University, Shanghai Children's Hospital, Shanghai Children's Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Enteral Feeding, Ventilator-Associated Pneumonia
    Keywords
    Enteral Feeding, Ventilator-Associated Pneumonia, Mechanical Ventilation, Pediatric Intensive Care Unit, Critical Illness

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intermittent enteral feeding
    Arm Type
    Active Comparator
    Arm Description
    Intermittent enteral feeding via the nasogastric tube is applied less than 30 mins.
    Arm Title
    Continuous enteral feeding
    Arm Type
    Active Comparator
    Arm Description
    Continuous enteral feeding via the nasogastric tube using infusion pump is applied for 24 hours.
    Intervention Type
    Other
    Intervention Name(s)
    Intermittent enteral feeding
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Continuous enteral feeding
    Intervention Description
    The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube for 24 hours.
    Primary Outcome Measure Information:
    Title
    Ventilator-associated pneumonia
    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.
    Time Frame
    at Day-28
    Secondary Outcome Measure Information:
    Title
    Duration of ICU stay
    Time Frame
    at Day-28
    Title
    Duration of hospital stay
    Time Frame
    at Day-28
    Title
    ICU mortality
    Time Frame
    at Day-28
    Title
    Hospital mortality
    Time Frame
    at Day-28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    29 Days
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age of 29 days to 16 years. Subjects ventilated over or equal to 12 hours. Endotracheal intubation. Subjects without contraindication for enteral feeding. Exclusion Criteria: Newborn or age > or equal to 16 years. Subjects has been ventilated before this research. Subjects ventilated less than 12 hours. Invasive ventilation. Subjects with severe congenital malformations.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yueniu Zhu, PhD
    Phone
    +86-21-25078999
    Ext
    8353
    Email
    zhuyueniu@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lingxuezi Zhang, MD
    Phone
    +86-21-25078999
    Ext
    8355
    Email
    zlxz1989@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiaodong Zhu, MD
    Organizational Affiliation
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yueniu Zhu, PhD
    Organizational Affiliation
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs

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