[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05223192":3,"trial-entities:NCT05223192":97,"trial-summary:NCT05223192":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":14,"eligibility_criteria":56,"std_ages":66,"locations":68,"central_contacts":86,"overall_officials":93,"references":95,"see_also_links":96},"NCT05223192","STUDY-21-01783","The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants","RECRUITING","2026-12-31","2026-08","2026-08-13","2022-04-01","Icahn School of Medicine at Mount Sinai","OTHER",false,"Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention\u002Fsilence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.",null,[18],"Prematurity",[20,21,22,23,24],"music therapy","ocean disc","prematurity","vital signs","cerebral oxygenation","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},120,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Music Therapy Entrainment with Ocean Disc Intervention","The studied intervention regards live entrainment with the ocean disc. Entrainment involves the use of an external stimulus, in the case of this study, an ocean disc instrument. Motion of the disc creates sounds in synchrony with the breathing of the infant and then in turn can control and influence the infant's regulation of the breath.",[38],"Intervention group",[40,43,45,47,49],{"measure":41,"timeFrame":42},"Heart Rate","14 days",{"measure":44,"timeFrame":42},"Respiratory Rate",{"measure":46,"timeFrame":42},"Oxygen-Saturation Level",{"measure":48,"timeFrame":42},"Weight",{"measure":50,"description":51,"timeFrame":42},"Cerebral oxygen saturation","Cerebral oxygen saturation measured using NIRS",[],"ALL","24 Weeks","37 Weeks",{"inclusion":57,"exclusion":60,"raw_text":65},[58,59],"Newborns born at 24-37 weeks' gestation at Mount Sinai hospital","Newborn is considered appropriate for clinically indicated music therapy",[61,62,63,64],"Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)","Infant of uncertain viability (gestation \\\u003C23 weeks, birth weight \\\u003C500 grams)","Known or suspected genetic disorder (e.g., Trisomy 21)","Identified hearing disorder","Inclusion Criteria:\n\n* Newborns born at 24-37 weeks' gestation at Mount Sinai hospital\n* Newborn is considered appropriate for clinically indicated music therapy\n\nExclusion Criteria:\n\n* Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)\n* Infant of uncertain viability (gestation \\\u003C23 weeks, birth weight \\\u003C500 grams)\n* Known or suspected genetic disorder (e.g., Trisomy 21)\n* Identified hearing disorder",[67],"CHILD",[69],{"facility":70,"status":7,"city":71,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":83},"Mount Sinai Hospitals","New York","10003","United States",[75,80],{"name":76,"role":77,"phone":78,"email":79},"Joanne V Loewy, DA, LCAT, MT-BC","CONTACT","(212) 420-3484","joanne.loewy@mountsinai.org",{"name":81,"role":82},"Joanne V Loewy","PRINCIPAL_INVESTIGATOR",{"lat":84,"lon":85},40.71427,-74.00597,[87,89],{"name":88,"role":77,"phone":78,"email":79},"Joanne V Loewy, DA, MT-BC, LCAT",{"name":90,"role":77,"phone":91,"email":92},"Elizabeth Barone","212 420-2704","Elizabeth.Barone@mountsinai.org",[94],{"name":88,"affiliation":12,"role":82},[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Preterm Birth",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study where 118 premature infants will be randomly assigned to either receive music therapy with an ocean disc or a control (silence).","completed","Music Therapy for Respiratory Stability in Premature Infants","This study is looking at how music therapy, specifically using an \"ocean disc\" instrument, might help premature babies breathe more steadily and get enough oxygen to their brains. They are studying babies born between 24 and 37 weeks of pregnancy at Mount Sinai Hospital. The study will measure heart rate, breathing rate, and oxygen levels after 14 days to see if the music therapy makes a difference. Babies who are expected to survive for at least 24 hours and are suitable for music therapy can join. The study aims to enroll 118 infants.","Heart rate, respiratory rate, and oxygen saturation levels will be measured at 14 days after the intervention period.",93,"If your baby is in the treatment group, they will receive six intervention days over a two-week period, with three sessions per week. Each day will include both a silence period and a live ocean disc intervention.","Not stated in the trial record.",[],"v2"]