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
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
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
NCT ID
NCT02973347
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
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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