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

Official title

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

Overview

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

• Behavioral Evidence-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 improveme
• Other Routine Enteral Feeding Care
  1. The physician issues a medical order. 2. The nurse completes enteral feeding based on the standard routine care process.

Primary outcome measures

• Nurses' Compliance with Feeding Tube Practice Behavior [Time frame: through study completion，8 months]
• Energy Target Achievement Rate [Time frame: through study completion，8 months]

Secondary outcome measures (2)

• 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)]

Eligibility criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Prevention

Study locations

China · 1 center

• Children's Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT07441746 · CHFudanU1124

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗