Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT02806427
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance of a Calorically Dense Enteral Nutrition Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-29', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily percentage of caloric nutritional goal met', 'timeFrame': 'First 3 days in the ICU'}], 'secondaryOutcomes': [{'measure': 'Daily percentage of protein goal met', 'timeFrame': 'First 5 days in the ICU'}, {'measure': 'Adverse events and serious adverse events', 'timeFrame': 'First 5 days in the ICU'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Enteral Feeding']}, 'descriptionModule': {'briefSummary': 'This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with established enteral access receiving standard tube feeding formula in the ICU', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult aged \\> 18 years\n* Admitted to Medical ICU with expected admission of ≥ 3 days\n* Established enteral access\n* Having obtained his/her or legal representative's informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)\n* Lack of enteral access\n* Parenteral nutrition\n* Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, etc.)\n* Subject who in the Investigator's assessment cannot be expected to comply with study protocol\n* Currently participating in another conflicting clinical trial."}, 'identificationModule': {'nctId': 'NCT02806427', 'briefTitle': 'Tolerance of a Calorically Dense Enteral Nutrition Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Tolerance of a Calorically Dense Enteral Nutrition Formula', 'orgStudyIdInfo': {'id': '15.08.US.HCN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'enterally fed adults', 'description': 'Adults subjects with a condition for which a calorically dense enteral formula is appropriate, with established enteral access, anticipated to require enteral tube feeding for at least 3 days.', 'interventionNames': ['Other: Enteral Formula']}], 'interventions': [{'name': 'Enteral Formula', 'type': 'OTHER', 'armGroupLabels': ['enterally fed adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OUHSC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Karen Allen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma University Health Sciences Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}