Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT05369494
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2022-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infants Fed a Hydrolyzed Infant Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009844', 'term': 'Oligosaccharides'}], 'ancestors': [{'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Parent Perspectives Questionnaire', 'timeFrame': 'Study Day1 to Study Day 28', 'description': 'Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive with higher scores indicating better perception'}, {'measure': 'Formula Satisfaction Questionnaire', 'timeFrame': 'Study Day1 to Study Day 28', 'description': 'Parent completed questionnaire; 13 questions of up to 5 categories, scaled from positive to negative'}, {'measure': 'Infant Feeding and Stool Patterns Questionnaire', 'timeFrame': 'Study Day1 to Study Day 28', 'description': 'Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from always to never'}, {'measure': 'Health Care Utilization', 'timeFrame': 'Study Day1 to Study Day 28', 'description': 'Number of Visits'}, {'measure': 'Adverse Events', 'timeFrame': 'Study Day1 to Study Day 28', 'description': 'Parent reported adverse events'}], 'primaryOutcomes': [{'measure': 'Weight Maintenance', 'timeFrame': 'Study Day1 to Study Day 28', 'description': 'Change in weight for age z-score'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal Tolerance', 'timeFrame': 'Study Day1 to Study Day 28', 'description': 'Parent completed diary'}, {'measure': 'Weight', 'timeFrame': 'Study Day1 to Study Day 28', 'description': 'Weight gain per day in grams'}, {'measure': 'Length', 'timeFrame': 'Study Day1 to Study Day 28', 'description': 'Length gain per day in cm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Tolerance']}, 'descriptionModule': {'briefSummary': 'The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Days', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infant is 0 to 90 days of age at enrollment.\n* Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional\n* Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study\n* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.\n* Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study\n* Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional\n* Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study\n\nExclusion Criteria:\n\n* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development\n* Awareness of a positive drug screen in the mother or participant\n* Suspected maternal substance abuse including alcohol\n* Participation in another study that has not been approved as a concomitant study by AN\n* Participant is receiving oral or inhaled steroids\n* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent\n* Participant has received an amino acid-based formula"}, 'identificationModule': {'nctId': 'NCT05369494', 'briefTitle': 'Infants Fed a Hydrolyzed Infant Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Tolerance of Infants Fed a Hydrolyzed Infant Formula', 'orgStudyIdInfo': {'id': 'AL49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Product', 'description': 'Infant formula product consumed ad libitum as instructed for approximately 28 days; Powder formula mixed to 20 kcal/fl. oz.', 'interventionNames': ['Other: Hydrolyzed protein infant formula with oligosaccharides']}], 'interventions': [{'name': 'Hydrolyzed protein infant formula with oligosaccharides', 'type': 'OTHER', 'description': 'Hydrolyzed protein infant formula with oligosaccharides', 'armGroupLabels': ['Experimental Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Medical Group Pediatrics', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Javara Inc.', 'geoPoint': {'lat': 33.44873, 'lon': -84.45493}}, {'zip': '31210', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research 3259', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Springs Medical Research', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Meridian Clinical Research 3357', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77084', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Gentle Pediatrics', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Carlett Ramirez', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}