Clinical ImplementationNCT07441746
Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children
A study testing Evidence-based tube feeding care and Routine Enteral Feeding Care in people with Clinical Implementation and Standardized Tube Feeding Care, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study aims to evaluate the feasibility and effectiveness of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " (T/CNAS 45-2024) in a multicenter setting. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Clinical Implementation, Standardized Tube Feeding Care, Enteral Nutrition
- What is being tested?
- Evidence-based tube feeding care and Routine Enteral Feeding Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Nurses who have worked in the Pediatric Intensive Care Unit (PICU) for ≥ 3 months, completed the departmental training, and are capable of independently performing feeding tube procedures.
- Nurses who hold a valid and legal nursing license.
- Nurses who voluntarily participate in the study and sign the informed consent form.
- Critically ill children aged > 28 days and ≤ 18 years.
- Length of hospital stay ≥ 24 hours.
- Children receiving nutritional support via feeding tube during hospitalization.
- Parents or legal guardians of the child have signed the informed consent form, agreeing to the child's participation in the study.
Who cannot join
- Nurses who are trainees or interns.
- Nurses who are on leave or not on duty.
- Pediatric Patients：
- Children who are fed via gastrostomy or jejunostomy.
- Children who are in the transition phase from tube feeding to oral feeding and can partially consume food orally.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Children's Hospital of Fudan University
Shanghai, Minhang, China 201102
Ying Gu, +86 13816881726, guying0128@aliyun.com
About this study
Official title: Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children: A Multi-center, Stratified Cluster Randomized Controlled Trial
This study aims to evaluate the feasibility and effectiveness of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " (T/CNAS 45-2024) in a multicenter setting. Tube feeding is a critical intervention for maintaining the nutritional status of critically ill children, particularly when oral intake of sufficient nutrition is not possible. While there are established guidelines for enteral nutrition in adults, the specific needs of critically ill children have not been sufficiently addressed. This study, based on the "Grol and Wensing Implementation of Change Model" in implementation science, will guide the clinical implementation of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " across multiple centers. The goal is to provide practical evidence for the nationwide application of this standard, enhance the quality of tube feeding care for critically ill children, and ultimately improve clinical outcomes for these patients.
Read the detailed description
Tube feeding is the administration of liquid food, fluids, nutritional preparations, and medications directly into the gastrointestinal tract of a patient through an enteral feeding tube to meet their nutritional and therapeutic needs. In the treatment of critically ill children, tube feeding plays a vital role in maintaining nutritional status and preventing complications such as gastrointestinal failure. However, problems such as tube displacement, aspiration, excessive gastric residual volume, and abdominal distension may occur, increasing the risk of complications and potentially threatening the child's life. Therefore, standardized nursing practices are crucial.
Several enteral nutrition guidelines have been published internationally and domestically, which provide clear recommendations on nutritional assessment, early initiation of enteral nutrition, and ensuring adequate nutritional intake. However, these guidelines mainly focus on adults or nutritional protocols, with insufficient practical guidance on tube feeding care for children, especially critically ill children. To address this gap, the Chinese Nursing Association published the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " (T/CNAS 45-2024) in 2024, providing targeted clinical practice guidelines.
The "Standard" covers essential requirements, feeding preparation, speed control, monitoring during feeding, and post-feeding disposal, offering a standardized feeding process for critically ill children. Research has shown that following standardized processes significantly reduces adverse reactions such as vomiting and aspiration. However, differences in the environment, resources, and management models between healthcare institutions may affect the feasibility and effectiveness of implementing the "Standard" in clinical practice, and further research is needed to identify potential barriers and strategies for implementation.
This study, based on the Grol and Wensing Implementation of Change Model, aims to guide the clinical implementation of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " in multiple centers. The goal is to provide practical evidence for the nationwide adoption of the standard, improve tube feeding care quality, and ultimately enhance clinical outcomes for critically ill children.
- Being tested
- Evidence-based tube feeding care, Routine Enteral Feeding Care
- Keywords
- Tube feeding, Pediatric Intensive Care Unit, Grol and Wensing model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based tube feeding careBehavioural
- Conduct FAME Evaluation: Develop a specific and feasible proposal；
- Assess Current Performance: Conduct a baseline survey;
- Identify Facilitators and Barriers: Recognize factors that promote or hinder progress.
- Select and Develop Change Strategies: Choose and design a set of transformation strategies.
- Develop and Implement Action Plan: Create and execute an implementation plan with activities, tasks, and timelines.
- Integrate Improvements into Routine Practice: Embed the improvements into standard practices.
- Evaluate and Revise the Plan: Continuously monitor the plan's performance based on indicators and revise as needed.
Routine Enteral Feeding CareOther
- The physician issues a medical order.
- The nurse completes enteral feeding based on the standard routine care process.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based tube feeding care for critically ill children | Experimental | This arm will implement the "Standard for Tube Feeding Care of Critically Ill Children" (T/CNAS 45-2024) across multiple centers, monitoring changes in care quality, improving tube feeding practices, and identifying complications in critically ill pediatric patients. Receives: Behavioral: Evidence-based tube feeding care |
| Routine enteral feeding procedure | Active comparator | Enteral feeding will be conducted according to the existing nursing protocols for enteral nutrition in each participating center. Receives: Other: Routine Enteral Feeding Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurses' Compliance with Feeding Tube Practice Behavior
The total number of feeding tube procedures performed by nurses during the study period will serve as the denominator, while the number of procedures that adhere to best evidence practice guidelines will be the numerator, calculating the compliance rate of nurses' feeding tube practice behavior.
Measured: through study completion，8 months
Energy Target Achievement Rate
The ratio of the target energy required by the feeding protocol to the actual energy delivered to the patient, calculating the energy target achievement rate.
Measured: through study completion，8 months
Secondary outcomes (2)
Adverse Event Rate
The total number of adverse events (e.g., aspiration, tube displacement, gastrointestinal complications) occurring during feeding tube procedures will serve as the numerator, and the total number of feeding tube procedures will be the denominator, calculating the adverse event rate.
Measured: through study completion，8 months
Nurses' Knowledge Level on Feeding Tube Care
The "Nurses' Knowledge of Feeding Tube Care" questionnaire, a self-designed tool, will be used to assess the nurses' knowledge of feeding tube care, comparing the correct answer rates before and after the intervention to evaluate the effect of the educational intervention.
Measured: Baseline (first month of the study) and post-intervention (after completing the 7-month intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical ImplementationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, Shenzhen Children's Hospital, Anhui Provincial Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Ying Gu, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441746
- Sponsor's protocol ID
- CHFudanU1124
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children: A Multi-center, Stratified Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07441746
- Acronym / sponsor ID
- CHFudanU1124
- Keywords
- Tube feeding, Pediatric Intensive Care Unit, Grol and Wensing model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, Shenzhen Children's Hospital, Anhui Provincial Children's Hospital
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- 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.
This study aims to evaluate the feasibility and effectiveness of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " (T/CNAS 45-2024) in a multicenter setting. Tube feeding is a critical intervention for maintaining the nutritional status of critically ill children, particularly when oral intake of sufficient nutrition is not possible. While there are established guidelines for enteral nutrition in adults, the specific needs of critically ill children have not been sufficiently addressed. This study, based on the "Grol and Wensing Implementation of Change Model" in implementation science, will guide the clinical implementation of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " across multiple centers. The goal is to provide practical evidence for the nationwide application of this standard, enhance the quality of tube feeding care for critically ill children, and ultimately improve clinical outcomes for these patients.
Detailed description
Tube feeding is the administration of liquid food, fluids, nutritional preparations, and medications directly into the gastrointestinal tract of a patient through an enteral feeding tube to meet their nutritional and therapeutic needs. In the treatment of critically ill children, tube feeding plays a vital role in maintaining nutritional status and preventing complications such as gastrointestinal failure. However, problems such as tube displacement, aspiration, excessive gastric residual volume, and abdominal distension may occur, increasing the risk of complications and potentially threatening the child's life. Therefore, standardized nursing practices are crucial.
Several enteral nutrition guidelines have been published internationally and domestically, which provide clear recommendations on nutritional assessment, early initiation of enteral nutrition, and ensuring adequate nutritional intake. However, these guidelines mainly focus on adults or nutritional protocols, with insufficient practical guidance on tube feeding care for children, especially critically ill children. To address this gap, the Chinese Nursing Association published the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " (T/CNAS 45-2024) in 2024, providing targeted clinical practice guidelines.
The "Standard" covers essential requirements, feeding preparation, speed control, monitoring during feeding, and post-feeding disposal, offering a standardized feeding process for critically ill children. Research has shown that following standardized processes significantly reduces adverse reactions such as vomiting and aspiration. However, differences in the environment, resources, and management models between healthcare institutions may affect the feasibility and effectiveness of implementing the "Standard" in clinical practice, and further research is needed to identify potential barriers and strategies for implementation.
This study, based on the Grol and Wensing Implementation of Change Model, aims to guide the clinical implementation of the " Standard for Enteral Feeding Care in Critically Ill Pediatric Patients " in multiple centers. The goal is to provide practical evidence for the nationwide adoption of the standard, improve tube feeding care quality, and ultimately enhance clinical outcomes for critically ill children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evidence-based tube feeding care for critically ill children | Experimental | Behavioral: Evidence-based tube feeding careThis arm will implement the "Standard for Tube Feeding Care of Critically Ill Children" (T/CNAS 45-2024) across multiple centers, monitoring changes in care quality, improving tube feeding practices, and identifying complications in critically ill pediatric patients. |
| Routine enteral feeding procedure | Active comparator | Other: Routine Enteral Feeding CareEnteral feeding will be conducted according to the existing nursing protocols for enteral nutrition in each participating center. |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Critically ill children aged > 28 days and ≤ 18 years.
- Length of hospital stay ≥ 24 hours.
- Children receiving nutritional support via feeding tube during hospitalization.
- Parents or legal guardians of the child have signed the informed consent form, agreeing to the child's participation in the study.
Key exclusion criteria (5 listed)
- Pediatric Patients：
- Children who are fed via gastrostomy or jejunostomy.
- Children who are in the transition phase from tube feeding to oral feeding and can partially consume food orally.
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 |
|---|---|---|
| Evidence-based tube feeding care1. Conduct FAME Evaluation: Develop a specific and feasible proposal； 2. Assess Current Performance: Conduct a baseline survey; 3. Identify Facilitators and Barriers: Recognize factors that promote or hinder progress. 4. Select and Develop Change Strategies: Choose and design a set of transformation strategies. 5. Develop and Implement Action Plan: Create and execute an implementation plan with activities, tasks, and timelines. 6. Integrate Improvements into Routine Practice: Embed the improvements into standard practices. 7. Evaluate and Revise the Plan: Continuously monitor the plan's performance based on indicators and revise as needed. | Behavioural | Evidence-based tube feeding care for critically ill children |
| Routine Enteral Feeding Care1. The physician issues a medical order. 2. The nurse completes enteral feeding based on the standard routine care process. | Other | Routine enteral feeding procedure |
Primary outcome
Nurses' Compliance with Feeding Tube Practice Behavior
Time frame: through study completion，8 months
The total number of feeding tube procedures performed by nurses during the study period will serve as the denominator, while the number of procedures that adhere to best evidence practice guidelines will be the numerator, calculating the compliance rate of nurses' feeding tube practice behavior.
Energy Target Achievement Rate
Time frame: through study completion，8 months
The ratio of the target energy required by the feeding protocol to the actual energy delivered to the patient, calculating the energy target achievement rate.
2 secondary outcomes
Adverse Event Rate
Time frame: through study completion，8 months
Nurses' Knowledge Level on Feeding Tube Care
Time frame: Baseline (first month of the study) and post-intervention (after completing the 7-month intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Clinical Implementation
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Recruiting
Firearm Secure Storage Device Distribution RCT
Firearm Safety, Firearm Safety Storage
RecruitingObservational study
Physiotherapy Practice in Flemish Nursing Homes
Guideline Implementation, Physiotherapy
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.
Ying Gu study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based tube feeding care and Routine Enteral Feeding Care in people with Clinical Implementation and Standardized Tube Feeding Care, run by Children's Hospital of Fudan University at 1 site in China.
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 7 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: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siyi Wang (+86 19110916606, 24211170033@m.fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurses' Compliance with Feeding Tube Practice Behavior (time frame: through study completion，8 months). The study lists 2 primary outcomes in all. 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 2 Mar 2026.