Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:04 AM
Study NCT ID:
NCT07421635
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-pyloric Feeding and Feeding Intolerance in ARDS Patients Undergoing Prone Position Ventilation: a Single-center, Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of FI', 'timeFrame': 'at day 3', 'description': 'Incidence of feeding intolerance during enteral nutrition within 72 hours of initiating EN'}], 'secondaryOutcomes': [{'measure': 'Incidence of enteral nutrition-related complications', 'timeFrame': 'up to 3 days', 'description': 'Incidence of feeding-related complications during enteral nutrition'}, {'measure': 'ICU mortality', 'timeFrame': 'up to 24 months', 'description': 'the survival rate(survival/total) during ICU stay'}, {'measure': '28-day mortality', 'timeFrame': 'at day 28', 'description': 'mortality in Day 28'}, {'measure': 'VFDs at day 28', 'timeFrame': '28 days', 'description': 'defined as the number of days between successful weaning from MV and day 28 after study enrollment'}, {'measure': 'Length of ICU stay', 'timeFrame': 'up to 24 months', 'description': 'the number of days from ICU admission to ICU discharge or death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Outcomes']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 18 years old\n2. ARDS, defined by the Berlin standard\n3. patients receiving prone position ventilation treatment\n\nExclusion Criteria:\n\n1. No enteral nutrition within 4 days after initiation of invasive mechanical ventilation\n2. Duration of invasive mechanical ventilation \\<72 hours after initiation of enteral nutrition\n3. Prone positioning initiated \\>3 days after EN\n4. Duration of each prone session \\<12 hours\n5. Severe acute pancreatitis\n6. Contraindications to early enteral nutrition'}, 'identificationModule': {'nctId': 'NCT07421635', 'briefTitle': 'Post-pyloric Feeding and Feeding Intolerance in ARDS Patients Undergoing Prone Position Ventilation: a Single-center, Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Post-pyloric Feeding and Feeding Intolerance in ARDS Patients Undergoing Prone Position Ventilation: a Single-center, Retrospective Study', 'orgStudyIdInfo': {'id': 'prone nutrition'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'gastric feeding', 'description': 'Patients receiving gastric feeding'}, {'label': 'post-pyloric feeding', 'description': 'Patients receiving post-pyloric feeding'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'ling liu, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Intensive Care Unit, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Ling Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}