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

1. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

174

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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
Verfahren: 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
Aktiver Komparator: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of stroke-associated pneumonia within 7 days of onset
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hospital length of stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and Day 28
White blood cell count will be measured via venous blood sample.
Baseline and Day 28

Andere Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jinling Hospital, China

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juni 2026

Primärer Abschluss (Geschätzt)

16. Juni 2027

Studienabschluss (Geschätzt)

15. September 2027

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

5. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FEED-SAP

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Patient information will be de-identified

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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