Clinical OutcomesNCT07421635
Post-pyloric Feeding and Feeding Intolerance in ARDS Patients Receiving Prone Position Ventilation
An observational study of Clinical Outcomes, run by Southeast University, China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Outcomes
- How many people
- 319 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2016to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intensive care unit
Who may be able to join
- age ≥ 18 years old
- ARDS, defined by the Berlin standard
- patients receiving prone position ventilation treatment
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Clinical Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gastric feeding | Patients receiving gastric feeding | |
| post-pyloric feeding | Patients receiving post-pyloric feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of FI
Incidence of feeding intolerance during enteral nutrition within 72 hours of initiating EN
Measured: at day 3
Secondary outcomes (5)
Incidence of enteral nutrition-related complications
Incidence of feeding-related complications during enteral nutrition
Measured: up to 3 days
ICU mortality
the survival rate(survival/total) during ICU stay
Measured: up to 24 months
28-day mortality
mortality in Day 28
Measured: at day 28
VFDs at day 28
defined as the number of days between successful weaning from MV and day 28 after study enrollment
Measured: 28 days
Length of ICU stay
the number of days from ICU admission to ICU discharge or death
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start30 Jul 2016
- Primary completion30 Apr 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- ling liu, phD, Study director, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421635
- Sponsor's protocol ID
- prone nutrition
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-pyloric Feeding and Feeding Intolerance in ARDS Patients Undergoing Prone Position Ventilation: a Single-center, Retrospective Study
- ClinicalTrials.gov ID
- NCT07421635
- Acronym / sponsor ID
- prone nutrition
- Conditions
- Clinical Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 30 Jul 2016 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric feeding | – | –Patients receiving gastric feeding |
| post-pyloric feeding | – | –Patients receiving post-pyloric feeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care unit
Key inclusion criteria (3 listed)
- age ≥ 18 years old
- ARDS, defined by the Berlin standard
- patients receiving prone position ventilation treatment
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of FI
Time frame: at day 3
Incidence of feeding intolerance during enteral nutrition within 72 hours of initiating EN
5 secondary outcomes
Incidence of enteral nutrition-related complications
Time frame: up to 3 days
ICU mortality
Time frame: up to 24 months
28-day mortality
Time frame: at day 28
VFDs at day 28
Time frame: 28 days
Length of ICU stay
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ling liu, phD study director
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Outcomes, run by Southeast University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of FI (time frame: at day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.