Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-21 @ 3:50 PM
Study NCT ID:
NCT04247269
Status:
WITHDRAWN
Last Update Posted:
2022-06-09
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Review of Enteral Formulas in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Site closure due to Covid Pandemic', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutrition Intake', 'timeFrame': '12 months', 'description': 'Assessment of enteral formula calorie and protein intake compared to nutrition prescription'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '12 months', 'description': 'Weight in kilograms'}, {'measure': 'Length/height', 'timeFrame': '12 months', 'description': 'Length/height (based on age) in centimeters'}, {'measure': 'Formula volume consumption', 'timeFrame': '12 months', 'description': 'Assessment of enteral formula volume compared to nutrition prescription'}, {'measure': 'Stool frequency', 'timeFrame': '12 months', 'description': 'Number of stools reported in medical record'}, {'measure': 'Ventilator status', 'timeFrame': '12 months', 'description': 'Assessment of ventilator change; extubated or continued'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enteral Feeding Intolerance', 'Tube Feeding', 'Nutrition Disorder, Child']}, 'descriptionModule': {'briefSummary': 'Retrospective review of nutrition enteral formula data documented in medical records.', 'detailedDescription': 'This is a retrospective review to assess nutrition (calorie and protein) intake of enteral formula data documented in medical records of patients that consumed enteral tube feeding formulas at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population studied retrospectively will be children with a history of enteral tube feeding in a home setting and meeting inclusion/exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum 12 months enteral feeding\n* History of enteral feeding with intact or semi-elemental formula\n\nExclusion Criteria:\n\n* Medical records lacking enteral nutrition feeding use'}, 'identificationModule': {'nctId': 'NCT04247269', 'briefTitle': 'Review of Enteral Formulas in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Retrospective Review of Enteral Formulas in Medically Complex Children', 'orgStudyIdInfo': {'id': '19.02.US.HCN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enteral formula standard', 'description': 'Children fed an intact protein formula', 'interventionNames': ['Other: Enteral Tube Feeding']}, {'label': 'Enteral formula semi-elemental', 'description': 'Children fed a semi-elemental protein formula', 'interventionNames': ['Other: Enteral Tube Feeding']}], 'interventions': [{'name': 'Enteral Tube Feeding', 'type': 'OTHER', 'description': 'Enteral tube feeding', 'armGroupLabels': ['Enteral formula semi-elemental', 'Enteral formula standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43228', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Central Ohio Specialty Care', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Krysmaru AraujoTorres, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Société des Produits Nestlé (SPN)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}