Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 9:54 AM
Study NCT ID:
NCT04413994
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2020-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The NEO-VASC study is a multicentric, prospective, randomized, controlled, open and parallel group clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-05-30', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': '"five years of age"', 'description': 'Difference in fasting blood glucose between preterm- and term-born children at five years of age'}, {'measure': 'Blood pressure', 'timeFrame': '"five years of age"', 'description': 'Difference in blood pressure between preterm- and term-born children at five years of age'}, {'measure': 'Distensibility of the descending aorta', 'timeFrame': '"five years of age"', 'description': 'Difference in the distensibility of the descending aorta between preterm- and term-born children using validated echocardiographic protocols at five years of age Results will be compared to results of term-born children'}, {'measure': 'BMI', 'timeFrame': '"five years of age"', 'description': 'Difference in BMI between preterm- and term-born children at five years of age, weight in kilograms and height in meters will be combined to report BMI in kg/m2'}, {'measure': 'Insulin sensitivity', 'timeFrame': '"five years of age"', 'description': 'Difference in insulin sensitivity between preterm- and term-born children at five years of age'}, {'measure': 'Lipid profile', 'timeFrame': '"five years of age"', 'description': 'Difference in lipid profile between preterm- and term-born children at five years of age'}], 'primaryOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': '"First day of life" up to "five years of life"', 'description': 'Primary outcome is the difference in fasting blood glucose at five years of age'}, {'measure': 'Blood pressure', 'timeFrame': '"First day of life" up to "five years"', 'description': 'Primary outcome is the difference in blood pressure at five years of age'}, {'measure': 'Distensibility of aorta', 'timeFrame': '"First day of life" up to "five years"', 'description': 'Primary outcome is the difference in the distensibility of the descending aorta using validated echocardiographic protocols at five years of age'}], 'secondaryOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': '"First day of life" up to "24 months"', 'description': 'Secondary outcome is fasting glucose at a corrected age of one and two years.'}, {'measure': 'Blood pressure', 'timeFrame': '"First day of life" up to "24 months"', 'description': 'Secondary outcome is blood pressure at a corrected age of one and two years.'}, {'measure': 'BMI', 'timeFrame': '"First day of life" up to "five years"', 'description': 'Secondary outcome is BMI at five years of age, weight in kilograms and height in meters will be combined to report BMI in kg/m2'}, {'measure': 'Insulin sensitivity', 'timeFrame': '"First day of life" up to "five years"', 'description': 'Secondary outcome is insulin sensitivity at five years of age'}, {'measure': 'Lipid profile', 'timeFrame': '"First day of life" up to "five years"', 'description': 'Secondary outcome is lipid profile at five years of age'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prematurity', 'Vascular Aging']}, 'referencesModule': {'references': [{'pmid': '34332629', 'type': 'DERIVED', 'citation': 'Mitterer W, Binder C, Blassnig-Ezeh A, Auer-Hackenberg L, Berger A, Simma B, Wald M, Lee M, Kiechl-Kohlendorfer U. Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial. Trials. 2021 Jul 31;22(1):509. doi: 10.1186/s13063-021-05445-9.'}]}, 'descriptionModule': {'briefSummary': 'Early vascular aging has its origins in fetal and neonatal life. The NEOVASC clinical trial aims to determine the effects of an exclusive human milk diet in extremely preterm infants on long-term cardiovascular health.', 'detailedDescription': "Early vascular aging has its origins in fetal and neonatal life. This early period of life plays an important role in the development of obesity, high blood pressure, abnormalities in lipid metabolism and non-insulin dependent diabetes. Increased cardiovascular risk in formerly preterm infants constitutes a health problem of steadily growing relevance. Emerging evidence suggests that human milk feeding has substantial benefits to the health of all infants, especially for those born prematurely. Unfortunately, human milk alone does not provide sufficient concentrations of nutrients, especially calcium, phosphorus, protein, and fat needed for these infants to grow satisfactorily. For that purpose, fortifiers are used to help increase the nutritional value of human milk.\n\nThe NEOVASC study is a multicentric, prospective, randomized, controlled, open and parallel group clinical trial. A total of 200 extremely preterm infants and 100 term infants are recruited for the test and control group, respectively. Infants in the test group (i.e., premature neonates) are randomized to either:\n\n1. An exclusive human milk diet which contains mother's milk or pasteurized donor human milk and a human milk fortifier until 36 weeks of gestation; OR\n2. Human milk (as long as available) and a human milk fortifier (as long as human milk is available) until a maximum of 32 weeks of gestation and thereafter human milk with a bovine-based fortifier or preterm formula.\n\nAfter 36 weeks of gestation, human milk with a bovine-based fortifier or preterm formula is used in both groups. As a control group, term-born age-matched controls are included. Participants within this control group are not enrolled at the time of birth but instead recruited in various kindergartens at the age of five. Therefore, data from birth is taken from the mother-child-booklet, which contains clinical records about the pregnancy, birth and early life of children born in Austria. The total study duration is scheduled for 96 months with a recruitment phase of 36 months. Follow-up visits are planned at one, two and five years of age for the test group.\n\nThe purpose of the NEOVASC clinical trial is to characterize early life stressors by assessing the effects of a physiological (i.e., human milk-based) nutrition in extremely preterm infants during the vulnerable preterm period on the risk of metabolic and vascular complications in later life. Outcomes include predictors and intermediate components of cardiovascular disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Preterm-born group:\n\nInclusion Criteria:\n\n1. Extremely preterm infants with a birth weight of 500-1250g.\n2. Feeding is NPO or exclusive human milk prior to enrollment.\n3. Parent(s) willing to sign informed consent.-\n\nExclusion Criteria:\n\n1. Infants with a birth weight \\<500g or \\>1250g\n2. Subjects diagnosed with inborn errors of metabolism such as galactosemia, phenylketonuria\n3. Subjects who have not been NPO or fed exclusive human milk diet prior to enrollment.\n4. Presence of major congenital malformation.\n5. Presence of intestinal perforation or Stage 2 Necrotizing enterocolitis prior to enrollment.\n6. Parent(s) not willing to sign informed consent.\n7. Unable to participate for any reason based on the decision of the study investigator (e.g. unlikely to survive the study period).\n\nTerm-born group:\n\nInclusion criteria\n\n1. Term-born children with an adequate birth weight\n2. Parent(s) willing to sign informed consent\n\nExclusion criteria\n\n1. Subjects with acute or chronic illness\n2. Parent(s) not willing to sign informed consent'}, 'identificationModule': {'nctId': 'NCT04413994', 'acronym': 'NEOVASC', 'briefTitle': 'Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prolacta Bioscience'}, 'officialTitle': 'Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)', 'orgStudyIdInfo': {'id': 'NEOVASC'}, 'secondaryIdInfos': [{'id': '868624', 'type': 'OTHER_GRANT', 'domain': 'Austrian Research Promotion Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Randomized study product group', 'description': 'receiving study product (human milk fortifier "Humavant") until a gestational age of 36 weeks', 'interventionNames': ['Dietary Supplement: Humavant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Randomized control group', 'description': 'receiving study product until a gestational age of 32 weeks and reference product (bovine based fortifier or bovine formula) after 32 weeks of gestation', 'interventionNames': ['Dietary Supplement: Humavant']}, {'type': 'NO_INTERVENTION', 'label': 'Term control group', 'description': 'Term-born controls as a reference group for outcome parameters'}], 'interventions': [{'name': 'Humavant', 'type': 'DIETARY_SUPPLEMENT', 'description': "Premature infants are randomized to either:\n\n1. An exclusive human milk diet which contains mother's milk or pasteurized donor human milk and the human milk fortifier until 36 weeks of gestation; OR\n2. Human milk (as long as available) and the human milk fortifier (as long as human milk is available) until a maximum of 32 weeks of gestation and thereafter human milk with a bovine-based fortifier or preterm formula.\n\nAfter 36 weeks of gestation, human milk with a bovine-based fortifier or preterm formula is used in both groups. As a control group, term-born age-matched controls are included.", 'armGroupLabels': ['Randomized control group', 'Randomized study product group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ursula Kiechl-Kohlendorfer, MD, MSc', 'role': 'CONTACT', 'email': 'ursula.kohlendorfer@i-med.ac.at', 'phone': '+43 512 504 27309'}, {'name': 'Wolfgang Mitterer, MD', 'role': 'CONTACT', 'email': 'wolfgang.mitterer@student.i-med.ac.at'}, {'name': 'Christoph Binder, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Martin Wald, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Burkhard Simma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Ursula Kiechl-Kohlendorfer, MD, MSc', 'role': 'CONTACT', 'email': 'ursula.kohlendorfer@i-med.ac.at', 'phone': '+43 512 504 27309'}, {'name': 'Wolfgang Mitterer, MD', 'role': 'CONTACT', 'email': 'wolfgang.mitterer@student.i-med.ac.at', 'phone': '+43 670 2021490'}], 'overallOfficials': [{'name': 'Ursula Kiechl-Kohlendorfer, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Innsbruck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prolacta Bioscience', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'Federal University Teaching Hospital, Feldkirch, Austria', 'class': 'OTHER'}, {'name': 'Paracelsus Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ursula Kohlendorfer', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}