Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT03522558
Status:
UNKNOWN
Last Update Posted:
2018-05-16
First Post:
2018-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005183', 'term': 'Failure to Thrive'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D007228', 'term': 'Infant Nutrition Disorders'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-10', 'studyFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2018-05-10', 'lastUpdatePostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)', 'timeFrame': '4 months corrected gestational age (CGA)'}, {'measure': 'Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)', 'timeFrame': '8 months corrected gestational age (CGA)'}, {'measure': 'Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)', 'timeFrame': '12 months corrected gestational age (CGA)'}, {'measure': 'Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)', 'timeFrame': '1 year corrected gestational age (CGA)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with growth failure', 'timeFrame': '1 year corrected gestational age (CGA)', 'description': 'Growth failure ("Failure to Thrive") is defined as crossing 2 growth percentiles in a downward trajectory in the first year of life per child.'}, {'measure': 'Number of participants who are malnourished', 'timeFrame': '1 year corrected gestational age (CGA)', 'description': 'The Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition (AND/ASPEN) criteria are used for diagnosing pediatric malnutrition.'}, {'measure': 'Severity of malnutrition as assessed by the AND/ASPEN criteria', 'timeFrame': '1 year corrected gestational age (CGA)'}, {'measure': 'Number of emergency department visits', 'timeFrame': '1 year corrected gestational age (CGA)'}, {'measure': 'Number of hospitalizations', 'timeFrame': '1 year corrected gestational age (CGA)'}, {'measure': 'Length of stay', 'timeFrame': 'about 3 to 7 days', 'description': 'number of hospital days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth Failure in Medically Complex Infants', 'Growth Failure', 'Malnutrition in Medically Complex Infants', 'Malnutrition', 'Nutrition in Medically Complex Infants', 'Nutrition', 'Nutrition Disorder, Infant']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare standardized nutrition therapy provided by a registered dietitian (RD) at regularly scheduled intervals to usual care in terms of the ability to improve growth parameters in medically complex infants in the pediatric outpatient setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who are admitted between July, 2018 and June, 2019 to the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UT Health from a neonatal intensive care unit (NICU)\n\nExclusion Criteria:\n\n* short bowel syndrome,\n* requiring parenteral nutrition (PN)\n* active cancer"}, 'identificationModule': {'nctId': 'NCT03522558', 'briefTitle': 'Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting. A Quality Improvement Project', 'orgStudyIdInfo': {'id': 'HSC-MS-18-0276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standardized Medical Nutrition Therapy', 'description': 'Standardized Medical Nutrition Therapy will include nutrition assessment provided by a registered dietitian (RD) at initial clinic visit or first Well Child Check (WCC) and regularly scheduled nutrition follow-up at each WCC visit thereafter.', 'interventionNames': ['Behavioral: Standardized Medical Nutrition Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': "At the primary care provider's discretion, a nutrition consult can be requested for the RD to perform nutrition assessment or discuss the patient's plan without full nutrition assessment, as is current practice. Currently in the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UTHealth, providers consult the RD as deemed appropriate with no established criteria for when to include the RD in patient care. Usual care will not be modified by the study protocol.", 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Standardized Medical Nutrition Therapy', 'type': 'BEHAVIORAL', 'description': 'Standardized Medical Nutrition Therapy will include nutrition assessment provided by a registered dietitian (RD) at initial clinic visit or first Well Child Check (WCC) and regularly scheduled nutrition follow-up at each WCC visit thereafter.', 'armGroupLabels': ['Standardized Medical Nutrition Therapy']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': "At the primary care provider's discretion, a nutrition consult can be requested for the RD to perform nutrition assessment or discuss the patient's plan without full nutrition assessment, as is current practice. Currently in the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UTHealth, providers consult the RD as deemed appropriate with no established criteria for when to include the RD in patient care. Usual care will not be modified by the study protocol.", 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Candice R Poland, MS, RD, LD', 'role': 'CONTACT', 'email': 'Candice.R.Poland@uth.tmc.edu', 'phone': '713-486-6961'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Candice R Poland, MS, RD, LD', 'role': 'CONTACT', 'email': 'Candice.R.Poland@uth.tmc.edu', 'phone': '713-486-6961'}], 'overallOfficials': [{'name': 'Candice R Poland, MS, RD, LD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registered Dietitian', 'investigatorFullName': 'Candice Rachel Poland', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}