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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Enteral Nutrition; Clinical Implementation; Standardized Tube Feeding Care
• Intervention / Treatment: Behavioral: Evidence-based tube feeding care; Other: Routine Enteral Feeding Care

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siyi Wang; Phone Number: +86 19110916606; Email: 24211170033@m.fudan.edu.cn

Study Locations

• China
  • Minhang
    • Shanghai, Minhang, China, China 201102
      • Children's Hospital of Fudan University
      • Contact: Ying Gu; Phone Number: +86 13816881726; Email: guying0128@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evidence-based tube feeding care for critically ill children; 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.	Behavioral: Evidence-based tube feeding care; 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.
Active Comparator: Routine enteral feeding procedure; Enteral feeding will be conducted according to the existing nursing protocols for enteral nutrition in each participating center.	Other: Routine Enteral Feeding Care; The physician issues a medical order.; The nurse completes enteral feeding based on the standard routine care process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	through study completion，8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline (first month of the study) and post-intervention (after completing the 7-month intervention)

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: The First Hospital of Jilin University; Shenzhen Children's Hospital; Anhui Provincial Children's Hospital
• Investigators: Study Director: Ying Gu, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Tube feeding; Pediatric Intensive Care Unit; Grol and Wensing model
• Other Study ID Numbers: CHFudanU1124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No