NCT07421635

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2016

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

7.8 years

First QC Date

February 12, 2026

Last Update Submit

March 24, 2026

Conditions

Clinical Outcomes

Outcome Measures

Primary Outcomes (1)

  • Incidence of FI

    Incidence of feeding intolerance during enteral nutrition within 72 hours of initiating EN

    at day 3

Secondary Outcomes (5)

  • Incidence of enteral nutrition-related complications

    up to 3 days

  • ICU mortality

    up to 24 months

  • 28-day mortality

    at day 28

  • VFDs at day 28

    28 days

  • Length of ICU stay

    up to 24 months

Study Arms (2)

gastric feeding

Patients receiving gastric feeding

post-pyloric feeding

Patients receiving post-pyloric feeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

intensive care unit

You may qualify if:

  • age ≥ 18 years old
  • ARDS, defined by the Berlin standard
  • patients receiving prone position ventilation treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • ling liu, phD

    Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

July 30, 2016

Primary Completion

April 30, 2024

Study Completion

December 30, 2024

Last Updated

March 30, 2026

Record last verified: 2026-03