[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613115":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":30,"locations":35,"responsibleParty":53,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":86,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Calmer","EXPERIMENTAL","Infants in the Calmer group will have a Calmer\\* placed and left in their incubators for a minimum of 2 and maximum of 3 weeks and will receive treatment for a minimum cumulative total of 3 hours\u002Fday (i.e. time can be discontinuous).\n\nEach day, after the infant's parent rests for 10 minutes, the research and\u002For bedside nurse will record the heart and respiratory rates for a 2-minute period (or taken by the caregiver themselves after training by research\u002FNICU staff). The 1-minute average will be used to program Calmer for each infant that day to better simulate day-to-day changes in infant-parent contact. The values can be adjusted over the day as parents wish.\n\n\\*Calmer, a patented, therapeutic bed that mimics key aspects of skin-to-skin care (SSC) to reduce stress in preterm infants. Calmer fits into NICU incubators and delivers 3 key SSC stimuli: touch, breathing motion, and heartbeat sounds (rates individualized to each infant based on their parents' HR\u002FRR).",[13],"Device: Calmer",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Infants in the Control group will receive standard NICU care, including parent SSC.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","Calmer, a unique, patented, therapeutic bed that mimics key aspects of SSC that reduce stress in preterm infants. Calmer fits into NICU incubators and cribs, and delivers 3 key SSC stimuli: touch, breathing motion, and heartbeat sounds; the rates of the latter 2 stimuli are individualized to each infant based on their parents' breathing and heart rates. Calmer is designed to provide complementary care only when parents are not able to give SSC. It is not meant nor designed to replace human SSC, so will never be tested as such a replacement. Instead, Calmer was invented to enhance and optimize brain development in preterm infants by reducing stress during the NICU stay, when parents\u002Fcaregivers are not available for SSC. Our ultimate goal is to enable use of Calmer from an infant's admission to discharge, only during those times when caregivers are not available.",[9],[25,28],{"name":26,"affiliation":5,"role":27},"Manon Ranger, PhD","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":5,"role":27},"Liisa Holsti, PhD",[31],{"name":26,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","604-827-1382","manon.ranger@ubc.ca",[36],{"facility":37,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"BC Women's Hospital & Health Centre","Vancouver","British Columbia","V6H 3N1","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-123.11934,49.24966,{"lat":47,"lon":46},[50,51,52],{"name":26,"role":32,"phone":33,"phoneExt":18,"email":34},{"name":26,"role":27,"phone":18,"phoneExt":18,"email":18},{"name":29,"role":27,"phone":18,"phoneExt":18,"email":18},{"type":27,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Manon Ranger","Assistant Professor",[57],{"name":58,"class":6},"BC Children's Hospital Research Institute","100613115","calmer-brains-in-very-preterm-infants-100613115",false,"NCT07262385","Calmer Brains in Very Preterm Infants","Calmer Brains: A Pilot Randomized Trial to Explore Structural and Functional Brain Development in Preterm Infants","Inclusion Criteria:\n\n* Very preterm infants admitted to the NICU at the BC Women's Hospital\n\nExclusion Criteria: Infants who have\n\n* Congenital anomalies;\n* Born small for GA (per medical admission history);\n* History of birthing parent substance use in pregnancy;\n* Ongoing infection at the time of enrollment;\n* Pre-existing cardiovascular instability defined by shock\u002Fhypotension\u002Fneed for cardiovascular drugs;\n* Receiving paralytic drugs;\n* Major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage\u002Fstroke; VP shunt);\n* Beyond the 30th completed week GA (30 weeks + 6 days) at enrollment.","ALL","26 Weeks","30 Weeks",{"count":70,"type":71},20,"ESTIMATED","INTERVENTIONAL",[74],"NA","Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development. Calmer was invented to mimic key parts of parental holding (touch, heartbeat sounds and breathing motion) to help reduce stress if parents cannot be there to hold their infant. Using specialized brain scans done at full term, we will gather initial information in 22 infants born 3-4 months early to compare brain development in infants who receive Calmer at least 3 hours each day (+ regular NICU care) over 2-3 weeks with infants who have regular NICU care.",[77],"Premature Infant",[79,80,81,82,83,84,85],"Prematurity","Brain development","Stress","NICU","Pilot RCT","Feasibility","Calmer - therapeutic medical device","NOT_YET_RECRUITING","2025-11-21",{"date":89,"type":90},"2025-12-03","ACTUAL",{"date":92,"type":71},"2025-12-01",{"date":94,"type":71},"2027-09",{"name":5,"class":6},1]