[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623857":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":48,"collaborators":50,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Instituto de Investigacion Sanitaria La Fe","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EV supplementation in very preterm infants",null,"Infants born before 32 weeks of gestation will receive own mother's milk supplemented with extracellular vesicles isolated from donor human milk.",[13],"Dietary Supplement: Donor human milk extracellular vesicles (DHM-EVs)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIETARY_SUPPLEMENT","Donor human milk extracellular vesicles (DHM-EVs)","Infants born before 32 weeks of gestation will receive supplementation with extracellular vesicles isolated from donor human milk, in addition to standard nutritional care.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Julia Kuligowski, PhD","CONTACT","+34961246661","julia.kuligowski@uv.es",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"María Gormaz, PhD, MD","+34\u002F961245686","gormaz_mar@gva.es",[31],{"facility":32,"status":33,"city":34,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Hospital Universitario y Politécnico La Fe","RECRUITING","Valencia","46026","Spain","ES",{"type":39,"coordinates":40},"Point",[41,42],-0.37966,39.47391,{"lat":42,"lon":41},[45,46],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":22,"role":47,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[51],{"name":52,"class":6},"Hospital Universitario La Fe","100623857","administration-of-extracellular-vesicles-from-donor-human-milk-in-preterm-infants-100623857",false,"NCT07402083","Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants","Administration of Extracellular Vesicles Isolated From Donor Human Milk as a Dietary Supplement for the Prevention of Necrotizing Enterocolitis in Preterm Infants","AdVEMPrem","Inclusion Criteria:\n\n* Preterm infants born at \\\u003C32 weeks gestational age\n* Age between 0 and 14 days of life at enrollment\n* At risk of developing necrotizing enterocolitis (NEC)\n* Written informed consent obtained from parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n* Major congenital anomalies or chromosomal abnormalities\n* Severe gastrointestinal malformations (e.g., gastroschisis, intestinal atresia)\n* Conditions incompatible with enteral feeding or EV supplementation\n* Participation in another interventional clinical trial","ALL","0 Days","14 Days",{"count":65,"type":66},20,"ESTIMATED","OBSERVATIONAL","The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing enterocolitis (NEC). NEC is a dangerous condition that affects the intestines of preterm infants and can lead to long-term health issues.\n\nHuman milk is the best nutrition for babies, but when a mother's own milk is not available, donor human milk (DHM) is used. EVs in milk carry proteins, fats, and genetic material that may support gut development, immunity, and brain growth. While laboratory studies suggest EVs are beneficial, their effects in premature babies have not yet been proven.\n\nIn this study, 20 very preterm infants (\\\u003C32 weeks of gestation) will be enrolled during their stay in the Neonatal Intensive Care Unit (NICU). All babies in the study will receive oral supplementation with EVs isolated from donor human milk. Researchers will monitor feeding tolerance, growth, intestinal health, and early development. Blood and urine samples will also be collected to study how EVs affect metabolism and stress markers.\n\nThe main goal is to see if EV supplementation is safe and well tolerated. Longer-term follow-up will explore whether EVs improve growth and neurodevelopment as the babies grow. This research could lead to new nutritional strategies to reduce NEC and improve outcomes for premature infants and their families.",[70],"Very Preterm Infants (\u003C32 Weeks of Gestation)",[72,73,74,75,76,77,78],"Preterm birth (\u003C32 weeks)","Donor human milk (DHM)","Extracellular vesicles (EVs)","Feeding tolerance","Necrotizing enterocolitis (NEC)","Neurodevelopment","Donor Human Milk Extracellular Vesicle (DHMEVs)","2026-02-09",{"date":81,"type":82},"2026-02-11","ACTUAL",{"date":84,"type":82},"2026-02-05",{"date":86,"type":66},"2029-12-31",{"name":5,"class":6},1]