Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-28 @ 12:02 AM
Study NCT ID:
NCT02779335
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2016-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enteral Formula Tolerance in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-20', 'studyFirstSubmitDate': '2016-03-18', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily percentage of caloric nutritional goal met', 'timeFrame': '9 days'}], 'secondaryOutcomes': [{'measure': 'Daily percentage of protein goal met', 'timeFrame': '9 days'}, {'measure': 'Daily assessment of gastrointestinal tolerance - stool consistency', 'timeFrame': '9 days', 'description': 'Daily assessment of stool consistency (liquid, formed, soft)'}, {'measure': 'Daily assessment of gastrointestinal tolerance- Stool frequency', 'timeFrame': '9 days', 'description': 'Daily assessment of number of stool'}, {'measure': 'Daily assessment of gastrointestinal tolerance- Vomit', 'timeFrame': '9 days', 'description': 'Daily assessment of frequency of vomit'}, {'measure': 'Daily assessment of gastrointestinal tolerance - Flatulence', 'timeFrame': '9 days', 'description': 'Daily assessment of presence of flatulence'}, {'measure': 'Daily assessment of gastrointestinal tolerance - Abdominal pain', 'timeFrame': '9 days', 'description': 'Daily assessment of abdominal pain'}, {'measure': 'Frequency and nature of adverse events', 'timeFrame': '9 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tube-fed', 'Formula Tolerance', 'Pediatric Patients'], 'conditions': ['Enteral Nutrition']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.', 'detailedDescription': 'In this prospective study, a population of stable, tube-fed children will consume a standard polymetric tube feeding formula to assess ability to achieve enteral feeding goals and tolerance outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1 - 13 years of age\n* Currently tolerating enteral feeding\n* Has enteral access\n* Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 9 days\n* Having obtained his/her and/or his/her legal representative's informed consent\n\nExclusion Criteria:\n\n* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)\n* Lack of enteral access\n* Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)\n* Judged to be at risk for poor compliance to the study protocol\n* Lack of informed consent\n* Currently participating in another conflicting clinical trial"}, 'identificationModule': {'nctId': 'NCT02779335', 'briefTitle': 'Enteral Formula Tolerance in Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Enteral Formula Tolerance in Pediatric Patients', 'orgStudyIdInfo': {'id': '15.09.US.HCN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Enteral formula tube feeding', 'description': 'Enteral fed children, ages 1-13, with establish enteral feeding access', 'interventionNames': ['Other: Enteral Formula']}], 'interventions': [{'name': 'Enteral Formula', 'type': 'OTHER', 'description': 'pediatric subjects will be fed a standard pediatric enteral formula tube feeding', 'armGroupLabels': ['Enteral formula tube feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': "Children's Center for GI and Nutrition", 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}], 'overallOfficials': [{'name': 'Gerard Minor, MMS, PA-C', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Center for GI and Nutrition"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}