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O estudo clínico NCT07441746 para Clinical Implementation, Standardized Tube Feeding Care, Nutrição enteral está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children 500 Pediátrico
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O estudo clínico NCT07441746 é um estudo intervencionista para Clinical Implementation, Standardized Tube Feeding Care, Nutrição enteral. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de março de 2026, com o objetivo de incluir 500 participantes. Coordenado por Children's Hospital of Fudan University e deve ser concluído em 1 de junho de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 2 de março de 2026.
Resumo
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...Mostrar mais
Descrição detalhada
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...Mostrar mais
Título oficial
Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children: A Multi-center, Stratified Cluster Randomized Controlled Trial
Condições médicas
Clinical ImplementationStandardized Tube Feeding CareNutrição enteralOutros IDs do estudo
- CHFudanU1124
Número NCT
Data de início (real)
2026-03
Última atualização postada
2026-03-02
Data de conclusão (estimada)
2027-06
Inscrição (estimada)
500
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
Tube feeding
Pediatric Intensive Care Unit
Grol and Wensing model
Pediatric Intensive Care Unit
Grol and Wensing model
Propósito principal
Prevenção
Alocação do design
Randomizado
Modelo de intervenção
Estudo cruzado
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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...Mostrar mais |
Comparador ativoRoutine 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. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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) |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto
Idade mínima
28 Days
Sexos elegíveis
Todos
- 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 UniversityContato central do estudo
Contato: Siyi Wang, +86 19110916606, [email protected]
1 Locais do estudo em 1 países
Minhang
Children's Hospital of Fudan University, Shanghai, Minhang, China 201102, China
Ying Gu, Contato, +86 13816881726, [email protected]