Enteral FeedingNCT02973347
Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs
A study testing Intermittent enteral feeding and Continuous enteral feeding in people with Enteral Feeding and Ventilator-Associated Pneumonia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 days to 16 years
- Conditions the study is for
- Enteral Feeding, Ventilator-Associated Pneumonia
- What is being tested?
- Intermittent enteral feeding and Continuous enteral feeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of 29 days to 16 years.
- Subjects ventilated over or equal to 12 hours.
- Endotracheal intubation.
- Subjects without contraindication for enteral feeding.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Enteral Feeding, Ventilator-Associated Pneumonia
- Being tested
- Intermittent enteral feeding, Continuous enteral feeding
- Keywords
- Enteral Feeding, Ventilator-Associated Pneumonia, Mechanical Ventilation, Pediatric Intensive Care Unit, Critical Illness
- Medical subject headings
- Pneumonia, Ventilator-Associated, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent enteral feedingOther
The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube less than 30 mins.
Continuous enteral feedingOther
The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent enteral feeding | Active comparator | Intermittent enteral feeding via the nasogastric tube is applied less than 30 mins. Receives: Other: Intermittent enteral feeding |
| Continuous enteral feeding | Active comparator | Continuous enteral feeding via the nasogastric tube using infusion pump is applied for 24 hours. Receives: Other: Continuous enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at Day-28
Secondary outcomes (4)
Duration of ICU stay
Measured: at Day-28
Duration of hospital stay
Measured: at Day-28
ICU mortality
Measured: at Day-28
Hospital mortality
Measured: at Day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Shanghai Children's Hospital, Shanghai Children's Medical Center
- Responsible party
- Sponsor
- Investigators
- Xiaodong Zhu, MD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineYueniu Zhu, PhD, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973347
- Sponsor's protocol ID
- XH-16-039
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intermittent and Continuous Enteral Feeding on Ventilator-associated Pneumonia in Pediatric ICUs
- ClinicalTrials.gov ID
- NCT02973347
- Acronym / sponsor ID
- XH-16-039
- Conditions
- Enteral Feeding, Ventilator-Associated Pneumonia
- Keywords
- Enteral Feeding, Ventilator-Associated Pneumonia, Mechanical Ventilation, Pediatric Intensive Care Unit, Critical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Shanghai Children's Hospital, Shanghai Children's Medical Center
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent enteral feeding | Active comparator | Other: Intermittent enteral feedingIntermittent enteral feeding via the nasogastric tube is applied less than 30 mins. |
| Continuous enteral feeding | Active comparator | Other: Continuous enteral feedingContinuous enteral feeding via the nasogastric tube using infusion pump is applied for 24 hours. |
Who may qualify
- Ages
- 29 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age of 29 days to 16 years.
- Subjects ventilated over or equal to 12 hours.
- Endotracheal intubation.
- Subjects without contraindication for enteral feeding.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent enteral feedingThe intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube less than 30 mins. | Other | Intermittent enteral feeding |
| Continuous enteral feedingThe intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube for 24 hours. | Other | Continuous enteral feeding |
Primary outcome
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.
4 secondary outcomes
Duration of ICU stay
Time frame: at Day-28
Duration of hospital stay
Time frame: at Day-28
ICU mortality
Time frame: at Day-28
Hospital mortality
Time frame: at Day-28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaodong Zhu, MD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Yueniu Zhu, PhD study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent enteral feeding and Continuous enteral feeding in people with Enteral Feeding and Ventilator-Associated Pneumonia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueniu Zhu, PhD (+86-21-25078999 ext. 8353, zhuyueniu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-associated pneumonia (time frame: at Day-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.