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Gastric Feeding for the Prevention of Stroke-Associated Pneumonia (FEED-SAP)

1 de junho de 2026 atualizado por: Xinfeng Liu, Jinling Hospital, China

Comparing Early Post-pyloric Feeding Versus Gastric Feeding for the Prevention of Stroke-Associated Pneumonia in Patients With Severe Ischemic Stroke

This randomized controlled trial aims to compare the effectiveness of early post-pyloric feeding versus gastric feeding in preventing SAP in patients with severe ischemic stroke. The main question to answer is whether post-pyloric feeding group is better than the gastric feeding group for preventing SAP.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This study adopts a multicenter-center, randomized controlled, parallel-group, open-label trial design. Patients with severe ischemic stroke who meet the inclusion criteria will be randomly assigned to the post-pyloric feeding group (experimental group) or the gastric feeding group (control group). Both groups will receive standard stroke treatment and care. The primary outcome measure is the incidence of SAP, with a follow-up period of 90 days. The sample size is 174 cases, with 87 cases per group.

Tipo de estudo

Intervencional

Inscrição (Estimado)

174

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Jinling Hospital, Medical School of Nanjing University, Nanjing
        • Contato:
        • Contato:
        • Subinvestigador:
          • Yahui Guo, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosis of severe ischemic stroke, with NIHSS score > 16 [15-16]
  • Confirmed dysphagia via swallowing assessment (Kubota Water Swallowing Test ≥ grade 3, or confirmed aspiration risk by FEES/VFSS)
  • Time from onset to enrollment ≤ 72 hours
  • Expected survival ≥ 7 days
  • Non-mechanically ventilated patients
  • Signed informed consent from patient or legal representative.

Exclusion Criteria:

  • Diagnosed with pneumonia upon admission
  • High risk of gastrointestinal bleeding or perforation
  • Intestinal obstruction or gastrointestinal obstruction
  • Severe liver or kidney dysfunction
  • Advanced malignant tumor
  • Pregnancy or breastfeeding
  • Refusal to participate in the study

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Post-Pyloric Feeding Group
A nasoenteric tube (Nuritia, 10Fr) will be placed within 24 hours of admission. The procedure involves elevating the head of the bed to approximately 30-45°, lubricating the tube with liquid paraffin, inserting it into the stomach using a blind insertion technique, then positioning the patient in the right lateral decubitus position. The insertion length will be approximately 75 cm. 200-500 ml of air and warm water will be injected into the stomach to open the pylorus. Gently, as the pylorus opens, the tube will be advanced beyond the ligament of Treitz. Digestive fluid will be aspirated for pH testing. Tube position (post-pyloric) will be confirmed by X-ray before initiating enteral nutrition support. An appropriate nutritional formula will be selected based on the patient's condition. The initial infusion rate will be 20 ml/h using a nutrition pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate wi
Procedimento: Post-Pyloric Feeding
A nasoenteric tube (Nuritia, 10Fr) will be placed within 24 hours of admission. The procedure involves elevating the head of the bed to approximately 30-45°, lubricating the tube with liquid paraffin, inserting it into the stomach using a blind insertion technique, then positioning the patient in the right lateral decubitus position. The insertion length will be approximately 75 cm. 200-500 ml of air and warm water will be injected into the stomach to open the pylorus. Gently, as the pylorus opens, the tube will be advanced beyond the ligament of Treitz. Digestive fluid will be aspirated for pH testing. Tube position (post-pyloric) will be confirmed by X-ray before initiating enteral nutrition support. An appropriate nutritional formula will be selected based on the patient's condition. The initial infusion rate will be 20 ml/h using a nutrition pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate wil
Comparador Ativo: Gastric Feeding Group
A nasogastric tube (Nuritia, 14Fr) will be placed within 24 hours of admission. The tube will be lubricated with liquid paraffin, inserted into the gastric cavity using a blind insertion technique, and properly fixed. Correct position will be confirmed by auscultation of air insufflation over the stomach before initiating enteral nutrition support. An appropriate nutritional formula will be selected based on the patient's condition. The initial infusion rate will be 20 ml/h using a nutrition pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate will be gradually increased by 10 mL every 4 hours based on patient tolerance until the daily target volume (25-30 kcal/kg/day) is achieved.
Procedimento: Gastric Feeding
A nasogastric tube (Nuritia, 14Fr) will be placed within 24 hours of admission. The tube will be lubricated with liquid paraffin, inserted into the gastric cavity using a blind insertion technique, and properly fixed. Correct position will be confirmed by auscultation of air insufflation over the stomach before initiating enteral nutrition support. An appropriate nutritional formula will be selected based on the patient's condition. The initial infusion rate will be 20 ml/h using a nutrition pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate will be gradually increased by 10 mL every 4 hours based on patient tolerance until the daily target volume (25-30 kcal/kg/day) is achieved.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of stroke-associated pneumonia within 7 days of onset
Prazo: 7 days of onset.
The diagnostic criteria for SAP will follow the 2019 Chinese Expert Consensus on the Diagnosis and Treatment of Stroke-Associated Pneumonia.
7 days of onset.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Hospital length of stay
Prazo: From date of admission to date of discharge, assessed up to 28 days
Length of patients stay in the hospital
From date of admission to date of discharge, assessed up to 28 days
90-day modified Rankin Scale (mRS) score
Prazo: 90 days after randomization
The distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment.
90 days after randomization
Time from admission to achieving enteral nutrition target
Prazo: From date of admission until enteral nutrition target is achieved, assessed up to 28 days
Enteral nutrition target is set as 25-30kcal/kg.
From date of admission until enteral nutrition target is achieved, assessed up to 28 days
Change from baseline in serum albumin level at Day 14
Prazo: Baseline and Day 14
Serum albumin will be measured via venous blood sample.
Baseline and Day 14
Change from baseline in serum albumin level at Day 28
Prazo: Baseline and Day 28
Serum albumin will be measured via venous blood sample
Baseline and Day 28
Change from baseline in white blood cell count at Day 14
Prazo: Baseline and Day 14
White blood cell count will be measured via venous blood sample.
Baseline and Day 14
Change from baseline in white blood cell count at Day 28
Prazo: Baseline and Day 28
White blood cell count will be measured via venous blood sample.
Baseline and Day 28

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Mortality within 28 days
Prazo: 28 days post-randomization.
Percentage of patients who die within 28 days post-randomization.
28 days post-randomization.
Incidence of Gastrointestinal Complications
Prazo: 28 days
Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.
28 days
Catheter-related Complications
Prazo: 28 days
Blockage, displacement, dislodgement
28 days
Change from baseline in serum total protein level at Day 14
Prazo: Baseline and Day 14
Serum total protein level will be measured via venous blood sample.
Baseline and Day 14
Change from baseline in serum prealbumin level at Day 14
Prazo: Baseline and Day 14
Serum prealbumin level will be measured via venous blood sample.
Baseline and Day 14
Change from baseline in serum transferrin level at Day 14
Prazo: Baseline and Day 14
Serum transferrin level will be measured via venous blood sample.
Baseline and Day 14
Change from baseline in serum total protein level at Day 28
Prazo: Baseline and Day 28
Serum total protein will be measured via venous blood sample
Baseline and Day 28
Change from baseline in serum prealbumin level at Day 28
Prazo: Baseline and Day 28
Serum prealbumin will be measured via venous blood sample
Baseline and Day 28
Change from baseline in serum transferrin level at Day 28
Prazo: Baseline and Day 28
Serum transferrin will be measured via venous blood sample
Baseline and Day 28
Change from baseline in C-reactive protein level at Day 14
Prazo: Baseline and Day 14
C-reactive protein will be measured via venous blood sample.
Baseline and Day 14
Change from baseline in interleukin-6 level at Day 14
Prazo: Baseline and Day 14
Interleukin-6 level will be measured via venous blood sample.
Baseline and Day 14
Change from baseline in body temperature at Day 14
Prazo: Baseline and Day 14
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
Baseline and Day 14
Change from baseline in interleukin-6 level at Day 28
Prazo: Baseline and Day 28
Interleukin-6 level will be measured via venous blood sample.
Baseline and Day 28
Change from baseline in C-reactive protein level at Day 28
Prazo: Baseline and Day 28
C-reactive protein level will be measured via venous blood sample.
Baseline and Day 28
Change from baseline in body temperature at Day 28
Prazo: Baseline and Day 28
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
Baseline and Day 28

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Jinling Hospital, China

Investigadores

  • Investigador principal: Wusheng Zhu, MD, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

16 de junho de 2027

Conclusão do estudo (Estimado)

15 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

27 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2026

Primeira postagem (Real)

5 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • FEED-SAP

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Patient information will be de-identified

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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