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

1 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

174

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Procedure: 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
Actieve vergelijker: 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.
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of stroke-associated pneumonia within 7 days of onset
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hospital length of stay
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and Day 28
White blood cell count will be measured via venous blood sample.
Baseline and Day 28

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mortality within 28 days
Tijdsspanne: 28 days post-randomization.
Percentage of patients who die within 28 days post-randomization.
28 days post-randomization.
Incidence of Gastrointestinal Complications
Tijdsspanne: 28 days
Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.
28 days
Catheter-related Complications
Tijdsspanne: 28 days
Blockage, displacement, dislodgement
28 days
Change from baseline in serum total protein level at Day 14
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and Day 28
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
Baseline and Day 28

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Jinling Hospital, China

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 juni 2026

Primaire voltooiing (Geschat)

16 juni 2027

Studie voltooiing (Geschat)

15 september 2027

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FEED-SAP

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Patient information will be de-identified

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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