[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566054":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":23,"locations":33,"responsibleParty":67,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":12,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":36,"whyStopped":12,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of West Attica","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","NO_INTERVENTION","Preterm neonates will receive standard of care.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Music intervention","EXPERIMENTAL","Preterm neonates will be exposed to recorded music intervention. Recorded music will be played through a portable Bluetooth speaker (3.1 watt) placed in the incubator, which will be activated and controlled via a smartphone.",[18],"Other: Music intervention",[20],{"type":6,"name":14,"description":21,"armGroupLabels":22,"otherNames":12},"Recorded music created by a certified music therapist",[14],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":12,"email":28},"Dimitra Metallinou, Assistant Professor","CONTACT","2105387410","dmetallinou@uniwa.gr",{"name":30,"role":26,"phone":31,"phoneExt":12,"email":32},"Maria Tzeli, PhD candidate","6978815559","mtzeli@uniwa.gr",[34,52],{"facility":35,"status":36,"city":37,"state":12,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"General and Maternity Hospital of Athens Elena Venizelou","RECRUITING","Athens","11521","Greece","GR",{"type":42,"coordinates":43},"Point",[44,45],23.72784,37.98376,{"lat":45,"lon":44},[48],{"name":49,"role":26,"phone":50,"phoneExt":12,"email":51},"Aikaterini Fotiou, MD","00302132051000","katerinifg@hotmail.gr",{"facility":53,"status":54,"city":55,"state":12,"zip":56,"country":39,"countryCode":40,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Attikon General University Hospital","NOT_YET_RECRUITING","Chaïdári","12462",{"type":42,"coordinates":58},[59,60],23.66597,38.01135,{"lat":60,"lon":59},[63],{"name":64,"role":26,"phone":65,"phoneExt":12,"email":66},"Anna Daskalaki, NICU Director","00302105831298","annadaskalaki3@gmail.com",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Dimitra Metallinou","Assistant Professor",[72,73],{"name":35,"class":6},{"name":74,"class":6},"Attikon Hospital","100566054","investigation-of-the-effect-of-music-on-the-stress-of-preterm-neonates-through-innovative-applications-sonata-100566054",false,"NCT06650189","Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)","Investigation of the Effect of Music on the Stress of Preterm Neonates Through Innovative Applications","SONATA","Inclusion Criteria:\n\n* Born between 28 - 36+6 weeks of gestation\n* Absence of active infection including blood, urine, cerebrospinal fluid\n* Absence of congenital and genetic disorders and chromosomal abnormalities\n* Absence of nuclear jaundice\n* Absence of endocrine disorders\n* Absence of maternal use of illicit drugs prenatally\n* Non - sedated neonates\n* Positive bilateral transient evoked otoacoustic emissions\n* Stable clinical condition\n* Absence of brain injury\n\nExclusion Criteria:\n\n* Diagnosis of brain injury after the enrollment\n* Negative auditory brainstem response before discharge\n* Clinical deterioration","ALL","28 Weeks","37 Weeks",{"count":87,"type":88},70,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this prospective randomized clinical trial is to investigate the effect of music intervention on the stress of live born preterm neonates requiring admission to a Neonatal Intensive Care Unit, through the measurements of salivary biomarkers (hormones and proteins).\n\nThe main question it aims to answer is:\n\nCan the daily music intervention reduce the stress levels created by the Neonatal Intensive Care Unit environment in preterm neonates?\n\nResearchers will compare preterm neonates who will not be exposed to music intervention to investigate potential discrepancies in salivary stress biomarkers.\n\nParticipants will be exposed to recorded music for 5 consecutive days.",[94],"Premature Neonates",[96,97,98,99,100,101,102,103],"preterm neonates","premature neonates","stress","salivary biomarkers","NICU","preterm infants","premature infants","music","2025-03-26",{"date":106,"type":107},"2025-04-01","ACTUAL",{"date":109,"type":107},"2024-07-01",{"date":111,"type":88},"2026-07",{"name":5,"class":6},2]