Recorded Caregiver Voice for Neonatal Abstinence Syndrome
(VOICE-NAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Mohamed Habib, MD
Principal Investigator
University of Manitoba
Michael Narvey, MD
Principal Investigator
University of Manitoba
Are You a Good Fit for This Trial?
This trial is for newborns diagnosed with neonatal opioid withdrawal syndrome (NOWS) who are receiving care at two hospitals in Winnipeg. Parents or caregivers must be able to provide a voice recording. Specific inclusion and exclusion criteria are not detailed.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Recorded Parent/Caregiver Voice Playback
Trial Overview
The study is testing if playing recorded voices of parents or caregivers during feeding and settling times can be safely added to standard supportive care for infants with NOWS. About 15-20 babies will participate, and the main goal is to see if this approach works smoothly in routine hospital care.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All enrolled infants will receive standard Eat, Sleep, Console (ESC)-based care together with the recorded parent/caregiver voice intervention. A parent/caregiver 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/or immediately after feeding while the infant is settling or attempting to sleep. Direct parent/caregiver interaction and all clinically indicated care will take priority over recorded playback.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor
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