[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659270":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":56,"studyPopulation":52,"armGroups":57,"interventions":64,"overallOfficials":70,"centralContacts":77,"locations":85,"responsibleParty":120,"collaborators":52,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":52,"studyType":137,"phases":138,"briefSummary":139,"conditions":140,"keywords":145,"overallStatus":159,"whyStopped":52,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"University of Manitoba","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Proportion of Enrolled Infants With a Usable Parent\u002FCaregiver Voice Recording Obtained","Number of enrolled infants for whom a usable parent\u002Fcaregiver voice recording is successfully obtained, divided by the total number of enrolled infants, expressed as a percentage. A usable recording is one that can be used for protocol-defined playback.","From enrollment until the first usable parent\u002Fcaregiver voice recording is obtained, assessed up to 1 day after enrollment",{"measure":14,"description":15,"timeFrame":16},"Proportion of Prescribed Voice Playback Sessions Successfully Delivered","Number of protocol-prescribed recorded parent\u002Fcaregiver voice playback sessions successfully delivered, divided by the total number of prescribed playback sessions, expressed as a percentage. Sessions that are missed, withheld, interrupted, or discontinued will be documented together with the reason.","From the first planned playback session through completion of the intervention period, assessed up to 28 days after enrollment",[18,22,26,30,34],{"measure":19,"description":20,"timeFrame":21},"Proportion of Eligible Infants Enrolled","Number of eligible infants whose parent\u002Flegal guardian provides consent and who are enrolled, divided by the total number of eligible infants approached for participation, expressed as a percentage.","Throughout the recruitment period, approximately 12 months",{"measure":23,"description":24,"timeFrame":25},"Time From Enrollment to Availability of a Usable Parent\u002FCaregiver Voice Recording","Elapsed time between study enrollment and availability of the first usable parent\u002Fcaregiver voice recording for intervention delivery.","From enrollment until the first usable parent\u002Fcaregiver voice recording is available, assessed up to 1 day after enrollment",{"measure":27,"description":28,"timeFrame":29},"Occurrence of Infant Intolerance During Recorded Voice Playback","Number and proportion of infants with a documented behavioral or physiological concern temporally associated with playback that results in pausing, withholding, or discontinuing a session.","From the first playback session through completion of the intervention period, assessed up to 28 days after enrollment",{"measure":31,"description":32,"timeFrame":33},"Parent\u002FCaregiver Acceptability of the Recorded Voice Intervention","Acceptability of the intervention as assessed using the study-specific parent\u002Fcaregiver acceptability questionnaire, including perceived ease of providing the recording and acceptability of using recorded voice as part of the infant's supportive care. Results will be summarized descriptively.","At completion of the intervention period or before hospital discharge, whichever occurs first, assessed up to 28 days after enrollment",{"measure":35,"description":36,"timeFrame":37},"Frequency of Protocol Deviations and Intervention Delivery Problems","Number and type of protocol deviations, equipment or sound-delivery issues, workflow barriers, and other implementation problems occurring during study participation.","From initiation through completion of the intervention period, assessed up to 28 days after enrollment",[39,43],{"measure":40,"description":41,"timeFrame":42},"Pharmacologic Treatment for NOWS","Occurrence and amount of pharmacologic treatment for neonatal opioid withdrawal syndrome, including PRN and scheduled\u002Fmaintenance opioid therapy and adjunct medications where applicable.","From enrollment through hospital discharge, assessed over an anticipated period of up to 28 days",{"measure":44,"description":45,"timeFrame":46},"Hospital Length of Stay","Number of days from hospital admission to hospital discharge.","From hospital admission until hospital discharge, assessed over an anticipated period of up to 28 days",{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":52,"timePerspective":52,"maskingInfo":53},"NA","SINGLE_GROUP","Prospective, two-centre, single-group feasibility study. All enrolled infants receive standard Eat, Sleep, Console (ESC)-based care together with the recorded parent\u002Fcaregiver voice intervention. There is no randomization, comparator group, or crossover. The study is designed primarily to evaluate feasibility, tolerability, safety, and implementation within routine NICU care.","SUPPORTIVE_CARE",null,{"masking":54,"maskingDescription":55,"whoMasked":52},"NONE","No masking is used. The nature of the recorded parent\u002Fcaregiver voice intervention makes masking of caregivers, clinical staff, and investigators impractical.","VOICE-NAS is a prospective, two-site, single-arm feasibility study evaluating recorded parent\u002Fcaregiver voice playback as a non-pharmacologic adjunct to standard Eat, Sleep, Console (ESC)-based care for infants with neonatal opioid withdrawal syndrome (NOWS).\n\nApproximately 15-20 infants will be enrolled from the neonatal intensive care units at HSC Women's Hospital and St. Boniface Hospital in Winnipeg, Manitoba. Eligible infants will have prenatal opioid exposure and clinical NOWS requiring ongoing NICU management under an ESC-based approach. Opioid-associated polysubstance exposure will not exclude participation if the infant otherwise meets eligibility criteria.\n\nFollowing written informed consent from the parent\u002Flegal guardian, a participating parent\u002Fcaregiver will provide a recorded voice sample. Caregivers will be encouraged to speak naturally in their preferred or native language; English or French is not required. Recording content may include natural speech, reading, singing, storytelling, or comforting words. The research team is not required to translate the recording content.\n\nRecorded voice playback will be integrated into clinically appropriate feeding and settling periods. Playback may begin during the latter part of feeding and\u002For immediately after feeding while the infant is settling or attempting to sleep. Direct live parent\u002Fcaregiver interaction, including feeding, holding, skin-to-skin contact, talking, and consoling, will always take priority over recorded playback.\n\nThe initial standardized audio-delivery pathway will use the Dräger Babyleo TN500 developmental-care audio pathway when clinically and operationally available. Playback will be targeted at approximately 45-50 dB(A) at the infant position and will not exceed the protocol-defined maximum of 55 dB(A). Planned playback sessions will generally last approximately 20 minutes unless stopped earlier.\n\nPlayback will be withheld, paused, or discontinued if the infant develops signs of distress or clinical instability; if a clinical procedure, assessment, feeding need, or other care activity takes priority; if environmental conditions are unsuitable; if the parent\u002Fcaregiver requests that playback stop; if the treating clinical team considers continued playback inappropriate; or if the protocol-defined sound parameters cannot be maintained.\n\nThe study does not alter or delay standard NOWS management. Decisions regarding ESC care, feeding support, pharmacologic treatment, monitoring, transfer, or discharge will remain under the responsibility of the treating clinical team.\n\nThe primary focus is feasibility. Key feasibility outcomes will include successful acquisition of a usable parent\u002Fcaregiver voice recording and the proportion of prescribed playback sessions successfully delivered. Additional measures will include recruitment and consent, time to obtain a usable recording, missed or interrupted sessions and their reasons, protocol deviations, device or workflow issues, caregiver acceptability, staff implementation burden, tolerability, and completeness of study data.\n\nExploratory clinical variables will include routine ESC assessments, feeding support including nasogastric feeding where required, pharmacologic treatment for NOWS, cumulative medication exposure where available, treatment duration, medical readiness for discharge, and hospital length of stay.\n\nBecause this is a small feasibility study without a control group, analyses will be primarily descriptive and estimation-based. The study is not powered for efficacy testing, and no formal between-group hypothesis testing or multivariable modeling is planned. Findings will be used to refine the intervention and procedures and to inform the design of a future randomized efficacy trial.",[58],{"label":59,"type":60,"description":61,"interventionNames":62},"Recorded Parent\u002FCaregiver Voice Plus Standard ESC Care","EXPERIMENTAL","All enrolled infants will receive standard Eat, Sleep, Console (ESC)-based care together with the recorded parent\u002Fcaregiver voice intervention. A parent\u002Fcaregiver will provide a voice recording in their preferred or native language. Playback will be integrated into clinically appropriate feeding and settling periods, generally during the latter part of feeding and\u002For immediately after feeding while the infant is settling or attempting to sleep. Direct parent\u002Fcaregiver interaction and all clinically indicated care will take priority over recorded playback.",[63],"Behavioral: Recorded Parent\u002FCaregiver Voice Playback",[65],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":52},"BEHAVIORAL","Recorded Parent\u002FCaregiver Voice Playback","A participating parent\u002Fcaregiver will provide a recorded voice sample using natural speech in their preferred or native language. The recording may include talking, reading, singing, storytelling, or comforting words. The recording will be played to the infant during protocol-defined, clinically appropriate feeding and settling periods, generally during the latter part of feeding and\u002For immediately after feeding while the infant is attempting to settle or sleep.\n\nPlayback sessions will generally last approximately 20 minutes unless stopped earlier. Sound will be targeted at approximately 45-50 dB(A) at the infant position and will not exceed the protocol-defined maximum of 55 dB(A). Playback will be withheld, paused, or discontinued for infant distress or clinical instability, clinical procedures or care needs, direct parent\u002Fcaregiver interaction, unsuitable environmental conditions, parent\u002Fcaregiver request, treating-team concern, or inability to maintain protocol-defined sound paramet",[59],[71,74],{"name":72,"affiliation":5,"role":73},"Mohamed Habib, MD","PRINCIPAL_INVESTIGATOR",{"name":75,"affiliation":5,"role":76},"Michael Narvey, MD","STUDY_DIRECTOR",[78,82],{"name":72,"role":79,"phone":80,"phoneExt":52,"email":81},"CONTACT","431-998-8002","mhabib3@hsc.mb.ca",{"name":75,"role":79,"phone":83,"phoneExt":52,"email":84},"204-899-6845","mnarvey@hsc.mb.ca",[86,108],{"facility":87,"status":52,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"St. Boniface Hospital","Winnipeg","Manitoba","R2H 2A6","Canada","CA",{"type":94,"coordinates":95},"Point",[96,97],-97.14704,49.8844,{"lat":97,"lon":96},[100,104],{"name":101,"role":79,"phone":102,"phoneExt":52,"email":103},"Chelsea Ruth, MD","204-787-4998","chelsea.ruth@umanitoba.ca",{"name":105,"role":79,"phone":106,"phoneExt":52,"email":107},"Fabiana Postolow, MD","204-787-4992","FPOSTOLOW@hsc.mb.ca",{"facility":109,"status":52,"city":88,"state":89,"zip":110,"country":91,"countryCode":92,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"HSC Winnipeg Women's Hospital","R3A 1R9",{"type":94,"coordinates":112},[96,97],{"lat":97,"lon":96},[115,119],{"name":116,"role":79,"phone":117,"phoneExt":52,"email":118},"Julie Emberley, MD","204-787-1991","jemberley@hsc.mb.ca",{"name":105,"role":79,"phone":106,"phoneExt":52,"email":107},{"type":73,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Mohamed Habib","Neonatal-Perinatal Medicine Fellow \u002F Principal Investigator","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":135,"type":136},20,"ESTIMATED","INTERVENTIONAL",[48],"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.",[141,142,143,144],"Neonatal Opioid Withdrawal Syndrome","Prenatal Opioid Exposure","Opioid Withdrawal","Neonatal Abstinence Syndrome",[146,147,148,149,150,151,152,153,154,155,156,157,158],"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":162,"type":163},"2026-10-08","ACTUAL",{"date":165,"type":136},"2026-11-01",{"date":167,"type":136},"2027-12-01",{"name":5,"class":6},2]