[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557298":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":41,"locations":51,"responsibleParty":88,"collaborators":90,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":40,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":40,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":74,"whyStopped":40,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Music","EXPERIMENTAL","We will create three recordings with increasing complexity for each infant. For each infant developmental stage (32, 34, 36+ weeks PMA), Music Therapists (MTs) in both units will present parents with a curated list of 8-10 musically comparable, familiar lullabies to select from. Songs will be available in different languages reflective of patient diversity, with rhythm, tempo, pitch range\u002F change, instrumentation, melody, harmony selected drawing on available evidence, including BWH NICU pilot data. Timing: MBI to be administered after regular NICU \"care and feeding\" times, which are typically considered stressful times for infants. The goal of the intervention will be to provide a calming and relaxing experience to the infant as they \"settle\" back to sleep after handling times. Music delivery will occur via infant-adapted headphones to facilitate blinding.",[13],"Other: Music",{"label":15,"type":10,"description":16,"interventionNames":17},"Music and parent voice","The selected lullabies will be pre-recorded by the MT as described above to include a guitar accompaniment track, and a separate vocal track with the MT singing along, in two separate keys to allow variation for parent voice range and comfort. Parents will be invited to sing along with the recorded track of MT singing, and MT will later remove the MT-voice recording track so only the parent voice will be heard with the guitar in the final recording. Timing: MBI to be administered after regular NICU \"care and feeding\" times, which are typically considered stressful times for infants. The goal of the intervention will be to provide a calming and relaxing experience to the infant as they \"settle\" back to sleep after handling times. Music delivery will occur via infant-adapted headphones to facilitate blinding.",[18],"Other: Music and parent voice",{"label":20,"type":21,"description":22,"interventionNames":23},"Reference\u002F Standard of care","ACTIVE_COMPARATOR","These are infants recruited in the study who will receive the unit standard of care. They will be listening to the NICU ambient noise via infant-adapted headphones but will not receive any music intervention.",[24],"Other: Standard Care",[26,31,35],{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Arm 1: Music only",[9],[30],"Arm 1: Music",{"type":6,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"Arm 2: Music and parent voice",[15],[32],{"type":6,"name":36,"description":36,"armGroupLabels":37,"otherNames":38},"Standard Care",[20],[39],"Arm 3: Standard Care",null,[42,47],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Carmina Erdei, MD","CONTACT","6174620202","cerdei@bwh.harvard.edu",{"name":48,"role":44,"phone":49,"phoneExt":40,"email":50},"Isabella J Lawandy","4014901670","ilawandy@bwh.harvard.edu",[52,73],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Yale New Haven Hospital","NOT_YET_RECRUITING","New Haven","Connecticut","06510","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-72.92816,41.30815,{"lat":64,"lon":63},[67,70],{"name":68,"role":44,"phone":40,"phoneExt":40,"email":69},"Christine Henry","christine.henry@yale.edu",{"name":71,"role":72,"phone":40,"phoneExt":40,"email":40},"Angela Montgomery, MD","PRINCIPAL_INVESTIGATOR",{"facility":5,"status":74,"city":75,"state":76,"zip":77,"country":58,"countryCode":59,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"RECRUITING","Boston","Massachusetts","02115",{"type":61,"coordinates":79},[80,81],-71.05977,42.35843,{"lat":81,"lon":80},[84],{"name":85,"role":44,"phone":86,"phoneExt":40,"email":87},"Elizabeth Singh, MSN","5125165360","esingh@bwh.harvard.edu",{"type":72,"investigatorFullName":43,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Neonatologist",[91],{"name":92,"class":6},"Yale New Haven Health System Center for Healthcare Solutions","100557298","the-impact-of-music-medicine-on-preterm-brain-development-and-behavior-100557298",false,"NCT06536296","The Impact of Music Medicine on Preterm Brain Development and Behavior","The Impact of Music Medicine on Preterm Brain Development and Behavior - A Two-Center Randomized Controlled Trial \"The Lullaby Study\"","Inclusion Criteria:\n\n* Very preterm infants born between 24+0 and 30+6 weeks' gestational age (GA) from 2 level III NICUs (Brigham and Women's Hospital, Boston, MA and Yale New Haven, CT)\n* Infants who are medically stable per the clinical care team\n\nExclusion Criteria:\n\n* Infants with major genetic or congenital anomalies known to be associated with developmental delay\n* Infants with severe brain injury (such as intraparenchymal hemorrhage, severe white matter injury)\n* Infants who are severely ill infants for whom MBI is not feasible\n* Infants of parents who cannot complete questionnaires in English or Spanish.","ALL","24 Weeks","30 Weeks",{"count":104,"type":105},243,"ESTIMATED","INTERVENTIONAL",[108],"NA","The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork connectivity on term brain MRI, and language and other neurodevelopmental outcomes at two years corrected age. This is based on the hypothesis that infants in MPV arm are expected to experience the greatest benefit compared with infants receiving standard care.",[111,112,113,114],"Infant Development","Language Development","Prematurity","Stress",[116,117,118],"Preterm","Neurodevelopment","Music-based Intervention","2026-03-23",{"date":121,"type":122},"2026-03-25","ACTUAL",{"date":124,"type":122},"2025-05-19",{"date":126,"type":105},"2031-03-01",{"name":5,"class":6},2]