- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02973347
Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yueniu Zhu, PhD
- Phone Number: 8353 +86-21-25078999
- Email: zhuyueniu@hotmail.com
Study Contact Backup
- Name: Lingxuezi Zhang, MD
- Phone Number: 8355 +86-21-25078999
- Email: zlxz1989@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intermittent enteral feeding
Intermittent enteral feeding via the nasogastric tube is applied less than 30 mins.
|
The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube less than 30 mins.
|
Active Comparator: Continuous enteral feeding
Continuous enteral feeding via the nasogastric tube using infusion pump is applied for 24 hours.
|
The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube for 24 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilator-associated pneumonia
Time Frame: at Day-28
|
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.
|
at Day-28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of ICU stay
Time Frame: at Day-28
|
at Day-28
|
Duration of hospital stay
Time Frame: at Day-28
|
at Day-28
|
ICU mortality
Time Frame: at Day-28
|
at Day-28
|
Hospital mortality
Time Frame: at Day-28
|
at Day-28
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Xiaodong Zhu, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study Director: Yueniu Zhu, PhD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-16-039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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