[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053850":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":27,"responsibleParty":70,"collaborators":73,"id":80,"slug":10,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":10,"studyType":92,"phases":10,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"York University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Infants Hospitalized in the NICU",null,"Infants born between 25 0\u002F7 weeks 32 6\u002F7 weeks gestational age, who are within 8 weeks postnatal age, and their caregiver (if available) and\u002For health professional will be recruited for qualitative interview. Infants will participate in the study either in skin-to-skin contact with the birthing parent or in the cot if the parent is unable to participate. If the baby participates in a skin-to-skin study, they will be transferred from the cot to skin-to-skin following EEG electrode placement and a 10-minute cot baseline recording. Babies will be then exposed to a sham lance and a real lance while in skin-to-skin. For cot studies, babies are kept in the cot for the whole study duration, and thus the sham lance and real lance will be conducted while they are in the cot receiving standard care.",[13],{"name":14,"affiliation":15,"role":16},"Rebecca Pillai Riddell, PhD","York University\u002FMount Sinai Hospital","PRINCIPAL_INVESTIGATOR",[18,23],{"name":14,"role":19,"phone":20,"phoneExt":21,"email":22},"CONTACT","4167362100","ext. 20177","rpr@yorku.ca",{"name":24,"role":19,"phone":25,"phoneExt":10,"email":26},"Shah Vibhuti, MD","4165864816","Vibhuti.Shah@sinaihealth.ca",[28,48],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Mount Sinai Hospital","RECRUITING","Toronto","Ontario","M5G 1X5","Canada","CA",{"type":37,"coordinates":38},"Point",[39,40],-79.39864,43.70643,{"lat":40,"lon":39},[43,45],{"name":44,"role":19,"phone":25,"phoneExt":10,"email":26},"Vibhuti Shah, MD",{"name":46,"role":19,"phone":10,"phoneExt":10,"email":47},"Carol Cheng, MSc","carol.cheng@sinaihealth.ca",{"facility":49,"status":30,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"University College London Hospital","London","No Province","N1 2EP","United Kingdom","UK",{"type":37,"coordinates":56},[57,58],-0.12574,51.50853,{"lat":58,"lon":57},[61,66],{"name":62,"role":19,"phone":63,"phoneExt":64,"email":65},"Lorenzo Fabrizi, PhD","02031081888","Ext. 51888","l.fabrizi@ucl.ac.uk",{"name":67,"role":19,"phone":68,"phoneExt":10,"email":69},"Judith Meek, MD","020 3447 8094","judith.meek@nhs.net",{"type":16,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Rebecca Pillai Riddell","Full Professor",[74,76,78],{"name":75,"class":6},"MOUNT SINAI HOSPITAL",{"name":77,"class":6},"University College, London",{"name":79,"class":6},"University College London Hospitals","100053850",false,"NCT05579496","Rebooting Infant Pain Care: Using Machine Learning and Skin-to-Skin Contact to Exponentially Improve Neonatal Intensive Care Unit Practice","BabyAIBabyCalm","QUALITATIVE INTERVIEWS\n\nInclusion Criteria:\n\n* Parents of a child currently in the NICU or\n* Health professionals currently working in the NICU.\n\nExclusion Criteria:\n\n\\*Participants who cannot communicate fluently in English\n\nQUANTITITATIVE DATA CAPTURE (video, eeg, ecg, RR, SPo2)\n\nInclusion Criteria:\n\n* Infants born between 25 0\u002F7 weeks 32 6\u002F7 weeks gestational age\n* Infants who are within 8 weeks postnatal age\n* Infants who are undergoing a routine heel lance\n\nExclusion Criteria:\n\n* Infants with congenital malformations\n* Infants receiving analgesics or sedatives at the time of study (aside from sucrose)\n* Infants with history of perinatal hypoxia\u002Fischemia at the time of study\n* Infants with diaper rash or excoriated buttocks\n* Parents who are not fluent in English","ALL","25 Weeks","33 Weeks",{"count":90,"type":91},400,"ESTIMATED","OBSERVATIONAL","To address the current limitations related to infant pain assessment in the NICU, our international team of knowledge users and health\u002Fnatural science\u002Fengineering\u002Fsocial science researchers have come together to build a machine learning algorithm that will learn how to discriminate invasive and non-invasive distress. Furthermore, to improve the use of current pain management practices, our team seeks to better understand the developmental mechanisms underlying skin-to-skin contact over time and factors that may influence its efficacy in mitigating pain responses in preterm infants. This is an ongoing naturalistic observational study.",[95],"Acute Pain",[97,98,99,100,101,102],"NICU (Neonatal Intensive Care Unit)","Artificial Intelligence","Pain Assessment","Skin-to-Skin Contact","Parent Stress","Pain Management","2026-07-09",{"date":105,"type":106},"2026-07-13","ACTUAL",{"date":108,"type":106},"2020-11-01",{"date":110,"type":91},"2031-03",{"name":5,"class":6},2]