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Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children

Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children: A Multi-center, Stratified Cluster Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07441746
Enrollment
500
Registered
2026-03-02
Start date
2026-03-01
Completion date
2027-06-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Implementation, Enteral Nutrition, Standardized Tube Feeding Care

Keywords

Tube feeding, Pediatric Intensive Care Unit, Grol and Wensing model

Brief 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. 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.

Interventions

BEHAVIORALEvidence-based tube feeding care

1. 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.

OTHERRoutine Enteral Feeding Care

1. The physician issues a medical order. 2. The nurse completes enteral feeding based on the standard routine care process.

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER
The First Hospital of Jilin University
CollaboratorOTHER
Shenzhen Children's Hospital
CollaboratorOTHER_GOV
Anhui Provincial Children's Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Nurses: Inclusion Criteria: * 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.

Exclusion criteria

* Nurses who are trainees or interns. * Nurses who are on leave or not on duty. 2. Pediatric Patients: Inclusion: * 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. Exclusion: * 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.

Design outcomes

Primary

MeasureTime frameDescription
Nurses' Compliance with Feeding Tube Practice Behaviorthrough study completion,8 monthsThe 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 Ratethrough study completion,8 monthsThe ratio of the target energy required by the feeding protocol to the actual energy delivered to the patient, calculating the energy target achievement rate.

Secondary

MeasureTime frameDescription
Adverse Event Ratethrough study completion,8 monthsThe 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.
Nurses' Knowledge Level on Feeding Tube CareBaseline (first month of the study) and post-intervention (after completing the 7-month intervention)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.

Countries

China

Contacts

CONTACTSiyi Wang
24211170033@m.fudan.edu.cn+86 19110916606
STUDY_DIRECTORYing Gu

Children's Hospital of Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026