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.
VOICE-NAS is a two-centre feasibility study evaluating whether a recorded parent/caregiver 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.
A 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/or 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.
The 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.
Clinical 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.
Neonate receiving care at HSC Women's Hospital or St. Boniface Hospital.
Prenatal opioid exposure with clinical neonatal opioid withdrawal syndrome (NOWS).
Managed using an Eat, Sleep, Console (ESC)-based approach.
Requires NICU care or escalation of care for ongoing management of NOWS.
NICU admission primarily for prematurity or another medical condition unrelated to NOWS.
Withdrawal symptoms attributable solely to non-opioid substance exposure without prenatal opioid exposure.
Clinical condition in which the treating team considers recorded voice playback inappropriate or unsafe.
Any clinical or operational circumstance that prevents safe delivery of the intervention according to protocol.
Single group
Recorded Parent/Caregiver Voice Playback
BehavioralA participating parent/caregiver 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/or immediately after feeding while the infant is attempting to settle or sleep. Playback 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/caregiver interaction, unsuitable environmental conditions, parent/caregiver request, treating-team concern, or inability to maintain protocol-defined sound paramet
Proportion of Enrolled Infants With a Usable Parent/Caregiver Voice Recording Obtained
Number of enrolled infants for whom a usable parent/caregiver 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.
Proportion of Prescribed Voice Playback Sessions Successfully Delivered
Number of protocol-prescribed recorded parent/caregiver 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.
Proportion of Eligible Infants Enrolled
Number of eligible infants whose parent/legal guardian provides consent and who are enrolled, divided by the total number of eligible infants approached for participation, expressed as a percentage.
Time From Enrollment to Availability of a Usable Parent/Caregiver Voice Recording
Elapsed time between study enrollment and availability of the first usable parent/caregiver voice recording for intervention delivery.
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.
Parent/Caregiver Acceptability of the Recorded Voice Intervention
Acceptability of the intervention as assessed using the study-specific parent/caregiver 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.
Pharmacologic Treatment for NOWS
Occurrence and amount of pharmacologic treatment for neonatal opioid withdrawal syndrome, including PRN and scheduled/maintenance opioid therapy and adjunct medications where applicable.
Hospital Length of Stay
Number of days from hospital admission to hospital discharge.
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