ARDSNCT07362537
Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS
A study testing enteral nutrition through nasojejunal tube and enteral nutrition through nasogastric tube in people with ARDS, run by Southeast University, China at 1 site in China.
Trial summary
This pilot study is aimed to compare and assess the impact, safety, and practical utility of gastric versus postpyloric feeding in moderate to severe ARDS patients with prone position ventilation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ARDS
- What is being tested?
- enteral nutrition through nasojejunal tube and enteral nutrition through nasogastric tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARDS patients who meet the Berlin criteria for ARDS and have a P/F ratio ≤ 200mmHg.
- Patients receiving invasive mechanical ventilation and clinically judged to require prone ventilation, with an anticipated daily prone positioning time of ≥12 hours and a duration of prone ventilation therapy of ≥3 days.
- Patients planned to receive enteral nutrition.
- Age ≥18 and ≤85 years.
- Consent to sign an informed consent form.
Who cannot join
- Contraindications to enteral nutrition, such as severe intestinal ischemia, active upper gastrointestinal bleeding, high-output intestinal fistula without a distal feeding route, abdominal compartment syndrome, severe diarrhea, intestinal obstruction, etc.
- Presence of shock with hemodynamic instability (norepinephrine or equivalent vasopressor dosage ≥0.5ug/kg.min) or tissue hypoperfusion (lactate >3mmol/L).
- Life-threatening hypoxemia, hypercapnia, and acidosis.
- Inability to tolerate prone ventilation (e.g., pregnant women, limb contractures, recent fractures, recent thoracic or abdominal surgery, pacemaker insertion within 48 hours, spinal instability, pelvic fractures, facial fractures, anticipated difficult airway).
- Conditions preventing nasogastric or nasojejunal tube placement (e.g., esophageal rupture, severe esophageal varices).
- Anticipated inability to start enteral nutrition within 48 hours.
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- Use of prokinetic agents within 48 hours prior to starting enteral nutrition.
- Enteral nutrition via gastrostomy or jejunostomy.
- Expected ICU stay or survival time less than 3 days.
- Patients refusing further resuscitative treatment.
- Pregnant or breastfeeding women.
- Patients already enrolled in other interventional clinical studies or deemed unsuitable for the study by the clinician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda hospital, Southeast university
Nanjing, Jiangsu, 210009
Airan Liu, 862583262553, airanliu@126.com
airanliu@126.com
About this study
Official title: Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe Acute Respiratory Distress Syndrome: a Randomized Controlled Trial
This pilot study is aimed to compare and assess the impact, safety, and practical utility of gastric versus postpyloric feeding in moderate to severe ARDS patients with prone position ventilation. Patients included will be randomly assigned to receive enteral nutrition either through a nasogastric tube or a nasojejunal tube. The primary endpoint is the achievement of enteral nutrition goals. Secondary endpoints include the incidence of hospital-acquired infections, the number of ventilator-free days within 28 days, ICU length of stay, ICU mortality, 28-day mortality, 60-day mortality rates, the incidence of enteral nutrition intolerance, and the rate of enteral nutrition intake.
- Conditions
- ARDS
- Being tested
- enteral nutrition through nasojejunal tube, enteral nutrition through nasogastric tube
- Keywords
- ARDS, prone position ventilation, enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutrition through nasojejunal tubeProcedure or surgery
place nasojejunal tube for enteral nutrition
enteral nutrition through nasogastric tubeProcedure or surgery
place nasogastric tube for enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Post-pyloric feeding group | Experimental | Enteral nutrition through nasojejunal tube Receives: Procedure: enteral nutrition through nasojejunal tube |
| Gastric feeding group | Active comparator | Enteral nutrition through nasogastric tube Receives: Procedure: enteral nutrition through nasogastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Enteral Nutrition intake to target ratio
The ratio of total calorie and protein intake through EN to target calorie and protein respectively.
Measured: follow-up till 7-day
Secondary outcomes (8)
Incidence of new Infections
New infections occur after admission to ICU within 28 days after admission to this study
Measured: follow-up till 28-day
Ventilator-free days within 28 days
the number of days within a 28-day period that a patient does not require mechanical ventilation.
Measured: follow-up till 28-day
ICU Length of Stay
Duration of time a patient spends in the ICU from admission to discharge.
Measured: up to 24 weeks
ICU Mortality Rate
The proportion of patients who die in the Intensive Care Unit (ICU) of a hospital
Measured: up to 24 weeks
28-Day Mortality Rate
The proportion of patients who die within 28 days.
Measured: 28 days
60-Day Mortality Rate
The proportion of patients who die within 60 days.
Measured: 60 days
Incidence Rate of Enteral Nutrition Intolerance
The frequency at which patients experience intolerance to enteral feeding.
Measured: 28 days
Daily Enteral Nutrition Intake Rate
It is calculated as the total volume of enteral nutrition fed to a patient each day, divided by the total prescribed enteral nutrition for that day, multiplied by 100%.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362537
- Sponsor's protocol ID
- 20231030 prone nutrition
- Status last verified
- Jan 2026
- First submitted
- 1 Apr 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: by email
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe Acute Respiratory Distress Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07362537
- Acronym / sponsor ID
- 20231030 prone nutrition
- Conditions
- ARDS
- Keywords
- ARDS, prone position ventilation, enteral nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 23 Jan 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.
This pilot study is aimed to compare and assess the impact, safety, and practical utility of gastric versus postpyloric feeding in moderate to severe ARDS patients with prone position ventilation. Patients included will be randomly assigned to receive enteral nutrition either through a nasogastric tube or a nasojejunal tube. The primary endpoint is the achievement of enteral nutrition goals. Secondary endpoints include the incidence of hospital-acquired infections, the number of ventilator-free days within 28 days, ICU length of stay, ICU mortality, 28-day mortality, 60-day mortality rates, the incidence of enteral nutrition intolerance, and the rate of enteral nutrition intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-pyloric feeding group | Experimental | Procedure: enteral nutrition through nasojejunal tubeEnteral nutrition through nasojejunal tube |
| Gastric feeding group | Active comparator | Procedure: enteral nutrition through nasogastric tubeEnteral nutrition through nasogastric tube |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ARDS patients who meet the Berlin criteria for ARDS and have a P/F ratio ≤ 200mmHg.
- Patients receiving invasive mechanical ventilation and clinically judged to require prone ventilation, with an anticipated daily prone positioning time of ≥12 hours and a duration of prone ventilation therapy of ≥3 days.
- Patients planned to receive enteral nutrition.
- Age ≥18 and ≤85 years.
- Consent to sign an informed consent form.
Key exclusion criteria (12 listed)
- Contraindications to enteral nutrition, such as severe intestinal ischemia, active upper gastrointestinal bleeding, high-output intestinal fistula without a distal feeding route, abdominal compartment syndrome, severe diarrhea, intestinal obstruction, etc.
- Presence of shock with hemodynamic instability (norepinephrine or equivalent vasopressor dosage ≥0.5ug/kg.min) or tissue hypoperfusion (lactate >3mmol/L).
- Life-threatening hypoxemia, hypercapnia, and acidosis.
- Inability to tolerate prone ventilation (e.g., pregnant women, limb contractures, recent fractures, recent thoracic or abdominal surgery, pacemaker insertion within 48 hours, spinal instability, pelvic fractures, facial fractures, anticipated difficult airway).
- Conditions preventing nasogastric or nasojejunal tube placement (e.g., esophageal rupture, severe esophageal varices).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral nutrition through nasojejunal tubeplace nasojejunal tube for enteral nutrition | Procedure or surgery | Post-pyloric feeding group |
| enteral nutrition through nasogastric tubeplace nasogastric tube for enteral nutrition | Procedure or surgery | Gastric feeding group |
Primary outcome
Cumulative Enteral Nutrition intake to target ratio
Time frame: follow-up till 7-day
The ratio of total calorie and protein intake through EN to target calorie and protein respectively.
8 secondary outcomes
Incidence of new Infections
Time frame: follow-up till 28-day
Ventilator-free days within 28 days
Time frame: follow-up till 28-day
ICU Length of Stay
Time frame: up to 24 weeks
ICU Mortality Rate
Time frame: up to 24 weeks
28-Day Mortality Rate
Time frame: 28 days
60-Day Mortality Rate
Time frame: 60 days
Incidence Rate of Enteral Nutrition Intolerance
Time frame: 28 days
Daily Enteral Nutrition Intake Rate
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. by email
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition through nasojejunal tube and enteral nutrition through nasogastric tube in people with ARDS, run by Southeast University, China at 1 site in 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Airan Liu, PHD (+8615295557466, airanliu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Enteral Nutrition intake to target ratio (time frame: follow-up till 7-day). 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 23 Jan 2026.