Maternal Voice Recording for Premature Infants
Trial Summary
What is the purpose of this trial?
A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power density) as a marker of development.
Do I need to stop my current medications to participate in the trial?
The trial does not specify whether participants need to stop taking their current medications. However, infants receiving antiepileptic or sedation medications before the EEG are excluded from the trial.
What data supports the effectiveness of the treatment Placebo Recording, Recorded Maternal Voice for premature infants?
How is the treatment of recorded maternal voice unique for premature infants?
The treatment of recorded maternal voice is unique because it uses the mother's voice to potentially improve feeding, growth, and neural development in premature infants, unlike other treatments that may not focus on auditory stimulation. This approach leverages the familiar and comforting sound of the mother's voice to positively influence the infant's physiological and developmental outcomes.14678
Research Team
Aaron Cardon, MD
Principal Investigator
University of New Mexico, Health Sciences Center
Dawn Novak, MD
Principal Investigator
University of New Mexico, Health Sciences Center
Meghan Groghan
Principal Investigator
University of New Mexico, Health Sciences Center
Eligibility Criteria
This trial is for premature infants born between 28 and 32 weeks gestation, with mothers who can provide a voice recording in English. Infants with serious heart defects, genetic disorders, metabolic errors, neurological issues or on certain medications are excluded. Mothers under 18 or unable to consent are also not eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline EEG
Initial EEG of 60-90 minutes duration performed at 32 5/7 - 32 6/7 weeks
Intervention
Infants receive either recorded maternal voice or placebo for 2 weeks
Post-intervention EEG
Second EEG of 30-60 minutes duration performed between 35 0/7 - 35 6/7 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment until NICU discharge
Treatment Details
Interventions
- Placebo Recording
- Recorded Maternal Voice
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of New Mexico
Lead Sponsor