[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615630":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":59,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":32,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Azienda Ospedaliera di Perugia","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence AB: PMT then Quiet Rest","EXPERIMENTAL","Two period crossover. Period 1 = Personalized Music Therapy (PMT) during Phase 2 (10 to 40 min); Period 2 = Quiet Rest during Phase 2 (10 to 40 min). Washout between periods = 2 days. Each Period lasts 50 minutes (0 to 9 min Acclimation Rest; 10 to 40 min Treatment Exposure; 40 to 50 min Post-Exposure Rest). Measurements summarized as 5 minute window means at 5 to 9, 21 to 25, and 46 to 50 minutes.",[13,14],"Behavioral: Personalized Music Therapy (PMT)","Behavioral: Quiet Rest",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence BA: Quiet Rest then PMT","Two period crossover. Period 1 = Quiet Rest during Phase 2 (10 to 40 min); Period 2 = Personalized Music Therapy (PMT) during Phase 2 (10 to 40 min). Washout between periods = 2 days. Each Period lasts 50 minutes (0 to 9 min Acclimation Rest; 10 to 40 min Treatment Exposure; 40 to 50 min Post-Exposure Rest). Measurements summarized as 5 minute window means at 5 to 9, 21 to 25, and 46 to 50 minutes.",[13,14],[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Personalized Music Therapy (PMT)","Personalized Music Therapy (PMT): playback of the parent's recorded voice during Phase 2 (10 to 40 minutes) within a standardized 50 minute Period conducted in a low stimulation NICU room. Audio is prepared in advance by a trained music therapist (smoothing peaks, removing artifacts, setting a target level). Delivered via bedside speaker positioned approximately 30 cm from the infant's head; target intensity approximately 45 dBA (plus or minus 3 dB) at the infant's ear level. Phase 1 (0 to 9 minutes) and Phase 3 (40 to 50 minutes) are rest without added stimulation per protocol and are not part of the PMT exposure.",[9,16],[26,27],"Music Therapy","Parental voice",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Quiet Rest","Quiet Rest: low stimulation rest during Phase 2 (10 to 40 minutes) within the same standardized 50 minute Period used for PMT. Phase 1 (0 to 9 minutes) and Phase 3 (40 to 50 minutes) are also rest without added stimulation. Room conditions and handling minimization match those used for PMT.",[9,16],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Fabrizio Faina","CONTACT","+39 075 585 8021","fabrizio.faina@unipg.it",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Neonatal Intensive Care Unit (NICU), Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia","RECRUITING","Perugia","PG","06129","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],12.38878,43.1122,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":32,"email":58},"Marco Giulietti","+39 075 7883435","marco.giulietti@ospedale.perugia.it",{"type":60,"investigatorFullName":35,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Registered Nurse (RN), Azienda Ospedaliera di Perugia; Program Coordinator, Degree Program in Nursing, University of Perugia; Sponsor-Investigator",[63],{"name":64,"class":6},"University Of Perugia","100615630","personalized-music-therapy-for-preterm-infants-100615630",false,"NCT07295106","Personalized Music Therapy for Preterm Infants","Evaluation of the Effects of Personalized Music Therapy on Preterm Infants Admitted to the Neonatal Intensive Care Unit (NICU) and on Parental Stress: A Pilot Randomized Crossover Controlled Trial","Inclusion Criteria:\n\n* Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of Azienda Ospedaliera di Perugia, Santa Maria della Misericordia, Perugia (Italy) at the time of enrollment.\n* Gestational age at birth 28+0 to 36+6 weeks.\n* Age at enrollment: 5 to 15 days.\n* Stable vital signs at enrollment per unit policy.\n* Apgar score at 5 minutes ≥ 7.\n* Birth weight appropriate for gestational age, between the 50th and 90th percentile.\n* Written informed consent from parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n* Post-operative status at the time of enrollment.\n* One or more of the following: intraventricular hemorrhage, necrotizing enterocolitis, sepsis, significant pulmonary disease, or neonatal anemia.\n* Congenital anomalies.\n* Hypersensitivity or intolerance to sound.\n* Maternal history of drug and\u002For alcohol misuse during pregnancy.\n* Lack of parental consent.","ALL","5 Days","15 Days",{"count":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80],"NA","Preterm infants in the Neonatal Intensive Care Unit (NICU) face environmental and clinical stressors that may affect physiological stability and development. This pilot randomized crossover study tests Personalized Music Therapy (PMT) based on recorded parental voices versus Quiet Rest. Outcomes include tissue oxygenation index (TOI) via near-infrared spectroscopy (NIRS) and heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2). Each infant completes two Periods (PMT and Quiet Rest) in randomized order, separated by a 2-day washout. Parental stress is measured at discharge using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU). Findings inform feasibility, variance estimates, and protocol refinements for a larger trial.",[83,84],"Infant, Premature","Stress, Psychological",[86,87,26,88,89,90,91,92,93],"Neonatal Intensive Care Unit","NICU","Parental Voice","Tissue Oxygenation Index (TOI)","Respiratory Rate","Near-Infrared Spectroscopy (NIRS)","Heart Rate","Oxygen Saturation","2025-12-16",{"date":96,"type":97},"2025-12-19","ACTUAL",{"date":99,"type":97},"2025-10-13",{"date":101,"type":77},"2026-03",{"name":35,"class":6},1]