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

NCT07441746 | Not Yet Recruiting

• 1 other identifier: CHFudanU1124
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Implementation; Standardized Tube Feeding Care; Enteral Nutrition

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse Event Rate

  through study completion，8 months

• Nurses' Knowledge Level on Feeding Tube Care

  Baseline (first month of the study) and post-intervention (after completing the 7-month intervention)

Study Arms (2)

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.

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.

Other: Routine Enteral Feeding Care

Interventions

Evidence-based tube feeding care BEHAVIORAL

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.

Evidence-based tube feeding care for critically ill children

Routine Enteral Feeding Care OTHER

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

Routine enteral feeding procedure

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Nurses who are trainees or interns.
• Nurses who are on leave or not on duty.
• Pediatric Patients：
• 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.
• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• The First Hospital of Jilin University: collaborator
• Shenzhen Children's Hospital: collaborator
• Anhui Provincial Children's Hospital: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Minhang, China 201102, China

Location

Study Officials

• Ying Gu

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Siyi Wang

CONTACT

+86 19110916606; 24211170033@m.fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)