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Clinical Trial NCT07441746 for Clinical Implementation, Standardized Tube Feeding Care, Enteral Nutrition is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children 500 Pediatric
Clinical Trial NCT07441746 is an interventional study for Clinical Implementation, Standardized Tube Feeding Care, Enteral Nutrition and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2026 and continue until the study accrues 500 participants. Led by Children's Hospital of Fudan University, this study is expected to complete by 1 June 2027. The latest data from ClinicalTrials.gov was last updated on 2 March 2026.
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 nutr...Show More
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, p...Show More
Official Title
Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children: A Multi-center, Stratified Cluster Randomized Controlled Trial
Conditions
Clinical ImplementationStandardized Tube Feeding CareEnteral NutritionOther Study IDs
- CHFudanU1124
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-03-02
Completion Date (Estimated)
2027-06
Enrollment (Estimated)
500
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Tube feeding
Pediatric Intensive Care Unit
Grol and Wensing model
Pediatric Intensive Care Unit
Grol and Wensing model
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalEvidence-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. | 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...Show More |
Active ComparatorRoutine enteral feeding procedure Enteral feeding will be conducted according to the existing nursing protocols for enteral nutrition in each participating center. | 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
Secondary 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 |
| 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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
28 Days
Eligible Sexes
All
- 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.
- 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.
Children's Hospital of Fudan UniversityStudy Central Contact
Contact: Siyi Wang, +86 19110916606, [email protected]
1 Study Locations in 1 Countries
Minhang
Children's Hospital of Fudan University, Shanghai, Minhang, China 201102, China
Ying Gu, Contact, +86 13816881726, [email protected]