[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476917":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":40,"locations":49,"responsibleParty":69,"collaborators":18,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":18,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":95,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal exosomes administration","EXPERIMENTAL","ELWB newborns who will receive intranasal exosomes",[13],"Other: Exosomes derived from mesenchymal stromal cells (MSCs)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","ELWB newborns who will not receive intranasal exosomes",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"OTHER","Exosomes derived from mesenchymal stromal cells (MSCs)","Exosomes derived from mesenchymal stromal cells (MSCs) will be administered intranasal in ELBW infants",[9],[26,30,32,34,36,38],{"name":27,"affiliation":28,"role":29},"Oleg Ionov, PhD, MD","NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":29},"Ekaterina Balashova, PhD, MD",{"name":33,"affiliation":28,"role":29},"Denis Silachev, PhD, MD",{"name":35,"affiliation":28,"role":29},"Anna Kirtbaya, PhD, MD",{"name":37,"affiliation":28,"role":29},"Victor Zubkov, PhD, MD",{"name":39,"affiliation":28,"role":29},"Dmitriy Degtyarev, PhD, MD",[41,45],{"name":27,"role":42,"phone":43,"phoneExt":18,"email":44},"CONTACT","+74954382277","dr.ionov@hotmail.com",{"name":46,"role":42,"phone":47,"phoneExt":18,"email":48},"Diiana Sharafutdinova","+79859865567","dikarush@gmail.com",[50],{"facility":5,"status":18,"city":51,"state":18,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Moscow","117997","Russia","RU",{"type":56,"coordinates":57},"Point",[58,59],37.61781,55.75204,{"lat":59,"lon":58},[62,66,67],{"name":63,"role":42,"phone":64,"phoneExt":18,"email":65},"Elena A Gorodnova, PhD","+7 (495) 531-44-44","e_gorodnova@oparina4.ru",{"name":46,"role":42,"phone":47,"phoneExt":18,"email":48},{"name":68,"role":29,"phone":18,"phoneExt":18,"email":18},"Diiana RASHIDOVNA SHARAFUTDINOVA",{"type":70,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100476917","the-pilot-experimental-study-of-the-neuroprotective-effects-of-exosomes-in-extremely-low-birth-weight-infants-100476917",false,"NCT05490173","The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants","Inclusion Criteria:\n\n• Premature newborns of gestational age (GA) 25\u002F0-27\u002F6 weeks,\n\nExclusion Criteria:\n\n* Missing written parental consent\n* Damages to the nasal mucosa\n* Maxillofacial defects\n* Major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period)\n* Infants who died before 48 hours, infants in whom the clinical decision to withhold intensive care was made, infants who were not considered viable\n* Infants with edematous hemolytic disease of newborns, non-immune fetal dropsy,\n* Multifetal Gestations\n* Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study","ALL","1 Day","3 Days",{"count":81,"type":82},10,"ESTIMATED","INTERVENTIONAL",[85],"NA","To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25\u002F0-27\u002F6 weeks.",[88,89,90,91,92],"Premature Birth","Extreme Prematurity","Preterm Intraventricular Hemorrhage","Hypoxia-Ischemia, Cerebral","Neurodevelopmental Disorders",[94],"Extremely low birth weight, neuroprotection","NOT_YET_RECRUITING","2022-09-26",{"date":98,"type":99},"2022-09-28","ACTUAL",{"date":101,"type":82},"2022-10-05",{"date":103,"type":82},"2026-12-28",{"name":5,"class":6},1]