- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07421635
Post-pyloric Feeding and Feeding Intolerance in ARDS Patients Receiving Prone Position Ventilation
March 24, 2026 updated by: Ling Liu, Southeast University, China
Post-pyloric Feeding and Feeding Intolerance in ARDS Patients Undergoing Prone Position Ventilation: a Single-center, Retrospective Study
Evidence remains limited regarding the optimal enteral nutrition (EN) route for acute respiratory distress syndrome (ARDS) patients undergoing prone positioning.
This study aimed to explore the association of post-pyloric feeding with feeding intolerance (FI), specifically in that population.
Study Overview
Status
Completed
Conditions
Detailed Description
This single-center retrospective study included adult patients with ARDS who received prone position ventilation at Zhongda Hospital, Southeast University, between July 30, 2016, and April 30, 2024.
The primary outcome was the incidence of FI, defined as the failure to achieve an enteral energy intake of 17.5 kcal/kg/day within 72 hours of initiating EN.
The statistical approaches utilized included multivariate regression, inverse probability weighting model, and marginal structural cox model to ensure the robustness of our findings.
Subgroup analyses were also performed.
Study Type
Observational
Enrollment (Actual)
319
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
intensive care unit
Description
Inclusion Criteria:
- age ≥ 18 years old
- ARDS, defined by the Berlin standard
- patients receiving prone position ventilation treatment
Exclusion Criteria:
- No enteral nutrition within 4 days after initiation of invasive mechanical ventilation
- Duration of invasive mechanical ventilation <72 hours after initiation of enteral nutrition
- Prone positioning initiated >3 days after EN
- Duration of each prone session <12 hours
- Severe acute pancreatitis
- Contraindications to early enteral nutrition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
gastric feeding
Patients receiving gastric feeding
|
|
post-pyloric feeding
Patients receiving post-pyloric feeding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of FI
Time Frame: at day 3
|
Incidence of feeding intolerance during enteral nutrition within 72 hours of initiating EN
|
at day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
28-day mortality
Time Frame: at day 28
|
mortality in Day 28
|
at day 28
|
|
Incidence of enteral nutrition-related complications
Time Frame: up to 3 days
|
Incidence of feeding-related complications during enteral nutrition
|
up to 3 days
|
|
ICU mortality
Time Frame: up to 24 months
|
the survival rate(survival/total) during ICU stay
|
up to 24 months
|
|
VFDs at day 28
Time Frame: 28 days
|
defined as the number of days between successful weaning from MV and day 28 after study enrollment
|
28 days
|
|
Length of ICU stay
Time Frame: up to 24 months
|
the number of days from ICU admission to ICU discharge or death
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ling liu, phD, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2016
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
December 30, 2024
Study Registration Dates
First Submitted
February 12, 2026
First Submitted That Met QC Criteria
February 12, 2026
First Posted (Actual)
February 19, 2026
Study Record Updates
Last Update Posted (Actual)
March 30, 2026
Last Update Submitted That Met QC Criteria
March 24, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- prone nutrition
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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