Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome

VOICE-NAS is a prospective, two-site, single-arm feasibility study evaluating recorded parent/caregiver voice playback as a non-pharmacologic adjunct to standard Eat, Sleep, Console (ESC)-based care for infants with neonatal opioid withdrawal syndrome (NOWS).

Approximately 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.

Following written informed consent from the parent/legal guardian, a participating parent/caregiver 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.

Recorded voice playback will be integrated into clinically appropriate feeding and settling periods. Playback may begin during the latter part of feeding and/or immediately after feeding while the infant is settling or attempting to sleep. Direct live parent/caregiver interaction, including feeding, holding, skin-to-skin contact, talking, and consoling, will always take priority over recorded playback.

The 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.

Playback 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/caregiver requests that playback stop; if the treating clinical team considers continued playback inappropriate; or if the protocol-defined sound parameters cannot be maintained.

The 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.

The primary focus is feasibility. Key feasibility outcomes will include successful acquisition of a usable parent/caregiver 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.

Exploratory 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.

Because 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.