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Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Sponsor: University of Manitoba
Summary
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.
Official title: VOICE-NAS: Recorded Parent/Caregiver Voice as an Adjunct to Eat, Sleep, Console: A Two-Centre Prospective Single-Arm Feasibility Study
Key Details
Gender
All
Age Range
0 Days - 28 Days
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-11-01
Completion Date
2027-12-01
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Recorded Parent/Caregiver Voice Playback
A 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
Locations (2)
St. Boniface Hospital
Winnipeg, Manitoba, Canada
HSC Winnipeg Women's Hospital
Winnipeg, Manitoba, Canada