[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100394279":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":67,"collaborators":70,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":22,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":22,"overallStatus":46,"whyStopped":22,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Prolacta Bioscience","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Randomized study product group","ACTIVE_COMPARATOR","receiving study product (human milk fortifier \"Humavant\") until a gestational age of 36 weeks",[13],"Dietary Supplement: Humavant",{"label":15,"type":10,"description":16,"interventionNames":17},"Randomized control group","receiving study product until a gestational age of 32 weeks and reference product (bovine based fortifier or bovine formula) after 32 weeks of gestation",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Term control group","NO_INTERVENTION","Term-born controls as a reference group for outcome parameters",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"DIETARY_SUPPLEMENT","Humavant","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.",[15,9],[30],{"name":31,"affiliation":32,"role":33},"Ursula Kiechl-Kohlendorfer, MD, MSc","Medical University Innsbruck","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":22,"email":38},"CONTACT","+43 512 504 27309","ursula.kohlendorfer@i-med.ac.at",{"name":40,"role":36,"phone":41,"phoneExt":22,"email":42},"Wolfgang Mitterer, MD","+43 670 2021490","wolfgang.mitterer@student.i-med.ac.at",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Medical University of Innsbruck","RECRUITING","Innsbruck","Tyrol","A-6020","Austria","AT",{"type":53,"coordinates":54},"Point",[55,56],11.39454,47.26266,{"lat":56,"lon":55},[59,60,61,63,65],{"name":31,"role":36,"phone":37,"phoneExt":22,"email":38},{"name":40,"role":36,"phone":22,"phoneExt":22,"email":42},{"name":62,"role":33,"phone":22,"phoneExt":22,"email":22},"Christoph Binder, MD",{"name":64,"role":33,"phone":22,"phoneExt":22,"email":22},"Martin Wald, MD",{"name":66,"role":33,"phone":22,"phoneExt":22,"email":22},"Burkhard Simma, MD",{"type":33,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":32,"oldNameTitle":22,"oldOrganization":22},"Ursula Kohlendorfer","Professor",[71,74,76],{"name":72,"class":73},"Medical University of Vienna","OTHER",{"name":75,"class":73},"Federal University Teaching Hospital, Feldkirch, Austria",{"name":77,"class":73},"Paracelsus Medical University","100394279","exclusive-human-milk-in-preterm-neonates-and-early-vascular-aging-risk-factors-neovasc-100394279",false,"NCT04413994","Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)","Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)","NEOVASC","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 \\\u003C500g 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","ALL","1 Day","5 Years",{"count":90,"type":91},200,"ESTIMATED","INTERVENTIONAL",[94],"NA","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.",[97,98],"Prematurity","Vascular Aging","2025-08-22",{"date":101,"type":102},"2025-08-29","ACTUAL",{"date":104,"type":102},"2020-10-09",{"date":106,"type":91},"2028-06-01",{"name":5,"class":6},1]