[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prenatal-opioid-exposure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prenatal-opioid-exposure":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100659270","recorded-parentcaregiver-voice-for-infants-with-neonatal-opioid-withdrawal-syndrome-100659270",false,"NCT07864493","Recorded Parent\u002FCaregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome","VOICE-NAS: Recorded Parent\u002FCaregiver Voice as an Adjunct to Eat, Sleep, Console: A Two-Centre Prospective Single-Arm Feasibility Study","VOICE-NAS","Inclusion Criteria:\n\n* Neonate receiving care at HSC Women's Hospital or St. Boniface Hospital.\n* Prenatal opioid exposure with clinical neonatal opioid withdrawal syndrome (NOWS).\n* Managed using an Eat, Sleep, Console (ESC)-based approach.\n* Requires NICU care or escalation of care for ongoing management of NOWS.\n* Parent\u002Flegal guardian is able to provide informed consent for study participation.\n* A parent\u002Fcaregiver is willing and able to provide a usable voice recording for the intervention. The recording may be provided in the caregiver's preferred or native language.\n* Opioid-associated polysubstance exposure is permitted provided opioid exposure is present and the infant is being managed for NOWS.\n\nExclusion Criteria:\n\n* NICU admission primarily for prematurity or another medical condition unrelated to NOWS.\n\nRequirement for nasal continuous positive airway pressure (NCPAP\u002FCPAP) or other respiratory support for an independent respiratory condition at the time the intervention would be delivered.\n\n* Withdrawal symptoms attributable solely to non-opioid substance exposure without prenatal opioid exposure.\n* Clinical condition in which the treating team considers recorded voice playback inappropriate or unsafe.\n* Any clinical or operational circumstance that prevents safe delivery of the intervention according to protocol.\n* Parent\u002Flegal guardian consent cannot be obtained.","ALL","0 Days","28 Days",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","Neonatal opioid withdrawal syndrome (NOWS) can affect a newborn infant's ability to eat, sleep, and be consoled after exposure to opioids before birth. Standard care at the participating neonatal units uses the Eat, Sleep, Console (ESC) approach, which emphasizes supportive care and involvement of parents and caregivers.\n\nVOICE-NAS is a two-centre feasibility study evaluating whether a recorded parent\u002Fcaregiver voice can be safely and practically added to usual ESC-based care for infants with NOWS. Approximately 15 to 20 infants will be enrolled at HSC Women's Hospital and St. Boniface Hospital in Winnipeg, Manitoba.\n\nA parent or caregiver will make a short voice recording in their preferred or native language. The recording may include natural talking, reading, singing, storytelling, or comforting words. The recording will be played for the infant during clinically appropriate feeding and settling periods, usually during the latter part of a feed and\u002For after feeding while the infant is trying to settle or sleep. Playback will generally last about 20 minutes and will be delivered at a controlled sound level.\n\nThe main purpose of the study is to determine whether the intervention can be delivered consistently and safely within routine NICU care. The study will measure whether usable voice recordings can be obtained, how often planned playback sessions are successfully delivered, reasons sessions are missed or stopped, caregiver acceptability, staff workflow issues, and any signs of intolerance.\n\nClinical information such as ESC assessments, feeding support, medication treatment for NOWS, and hospital length of stay will also be described. The study is not designed to determine whether recorded voice therapy is effective. Results will be used to help design a future larger clinical trial.",[28,29,30,31],"Neonatal Opioid Withdrawal Syndrome","Prenatal Opioid Exposure","Opioid Withdrawal","Neonatal Abstinence Syndrome",[33,34,35,36,37,38,39,40,41,42,43,44,45],"Neonatal opioid withdrawal syndrome","NOWS","Neonatal abstinence syndrome","NAS","Eat, Sleep, Console","ESC","Parent\u002Fcaregiver voice","Recorded voice","Non-pharmacologic intervention","Prenatal opioid exposure","Neonatal intensive care unit","NICU","Feasibility study","NOT_YET_RECRUITING","2026-10-06",{"date":49,"type":50},"2026-10-08","ACTUAL",{"date":52,"type":22},"2026-11-01",{"date":54,"type":22},"2027-12-01",{"name":56,"class":57},"University of Manitoba","OTHER",2]