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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-18
SponsorChildren's Hospital of Fudan University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Nurses:

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • Routine Enteral Feeding Care

    Other intervention

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

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Evidence-based tube feeding care for critically ill childrenExperimental treatment 1 intervention
Group B: Routine enteral feeding procedureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion,8 months
2

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.

Time frame
through study completion,8 months

Secondary outcomes

1

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.

Time frame
through study completion,8 months
2

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.

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

Other outcomes

Sponsors and contacts

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Children's Hospital of Fudan University

Lead sponsor

The First Hospital of Jilin University

Collaborator

Shenzhen Children's Hospital

Collaborator

Anhui Provincial Children's Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: