Maternal Voice Recording for Premature Infants

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Must not be taking: Antiepileptics, Sedatives

Disqualifiers: Cardiac disease, Neurologic disorder, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether recordings of a mother's voice can aid brain development in premature infants. Babies born between 28 and 32 weeks of pregnancy, whose mothers can record their voices in English, might be suitable candidates. The trial will compare the effects of listening to their mother's voice versus silence on brain activity. As an unphased trial, this study provides a unique opportunity to enhance understanding of early brain development in premature infants.

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 prior data suggests that recorded maternal voice is safe for premature infants?

Research shows that playing a recording of a mother's voice to premature babies is safe. Studies have found no negative effects on vital signs, such as heart rate and breathing, when babies hear their mother's voice in the neonatal intensive care unit (NICU). Their important body functions remain normal during the recordings. Evidence also indicates that listening to their mother's voice can aid in sleep and development. Overall, this approach appears well-tolerated, with no reports of negative reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using recorded maternal voice for premature infants because it offers a non-invasive and comforting intervention that traditional treatments lack. Unlike typical care options, which often focus on medical and technological support, this approach harnesses the natural bonding element between mother and child. By playing a mother's voice, the treatment aims to promote neurological and psychological development in these vulnerable infants. The simplicity and personal nature of this method could potentially enhance developmental outcomes in a way that current treatments do not address.

What evidence suggests that recorded maternal voice is effective for development in premature infants?

Research has shown that playing a recording of a mother's voice to premature babies can aid brain growth. In this trial, some infants will hear a recorded maternal voice, which studies have found supports better brain development, particularly in language-related areas. Additionally, listening to their mother's voice can stabilize the babies' physical responses, such as heart rate and breathing. A review of several studies suggests that a mother's voice, whether sung or spoken, can positively affect the babies' language skills and social-emotional growth. These findings highlight the potential benefits of using recorded maternal voices to support the development of premature infants. ^{2 3 6 7 8}

Who Is on the Research Team?

Dawn Novak, MD

Principal Investigator

University of New Mexico, Health Sciences Center

Meghan Groghan

Principal Investigator

University of New Mexico, Health Sciences Center

Aaron Cardon, MD

Principal Investigator

University of New Mexico, Health Sciences Center

Are You a Good Fit for This Trial?

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

My baby was born between 28 and 32 weeks of pregnancy.

My mother can speak and read English and is available to provide a voice recording.

Exclusion Criteria

My infant is on medication for epilepsy or sedation before an EEG.

My mother cannot provide a voice recording in English.

My child is in foster care, will be adopted, or is a ward of the state.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline EEG

Initial EEG of 60-90 minutes duration performed at 32 5/7 - 32 6/7 weeks

1 week

1 visit (in-person)

Intervention

Infants receive either recorded maternal voice or placebo for 2 weeks

2 weeks

Daily sessions

Post-intervention EEG

Second EEG of 30-60 minutes duration performed between 35 0/7 - 35 6/7 weeks

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment until NICU discharge

Approximately 7-10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Recording
• Recorded Maternal Voice

Trial Overview The study tests the effect of recorded maternal voices versus placebo recordings on brain development markers in preterm infants using qEEG. It's a short-term randomized trial where neither the participants nor the researchers know which recording each infant receives.

How Is the Trial Designed?

Group I: Recorded Voice Exposure Experimental Treatment 1 Intervention

Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the intervention arm will be played a recording of their mother's voice with approximately 60 minutes of scripted content, once per 24 hours for a 2-week (14 day) intervention period. (Mothers will be recorded reading a children's book and the recording will be looped to create the 60 minutes of content).

Group II: Placebo Placebo Group 1 Intervention

Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the non-intervention arm will be played a blank recording of approximately 60 minutes duration, once every 24 hours for a 2-week (14 day) period.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38910112/

Maternal recorded voice played to preterm infants in ... Maternal recorded voice played to preterm infants in incubators reduces her own depression, anxiety and stress: a pilot randomized control trial.

2. med.stanford.edu med.stanford.edu/news/all-news/2025/10/mothers-voice-premature.html

Mom's voice boosts language-center development in ... Premature infants who heard recordings of their mothers' voices showed more advanced brain development. Todd Holland. News. Pediatrics October ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e101355

Effects of maternal singing or voice on language and social ... The overall aim of this systematic review is to assess the effects of maternal singing or voice, live or recorded, on the language and social-emotional ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163638316300959

Positive effects of low intensity recorded maternal voice on ... Low intensity recorded maternal voice has a stabilizing effect on premature infants' physiologic reactions. Low intensity recorded maternal voice significantly ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/14767058.2024.2362933

Maternal recorded voice played to preterm infants in ... In this pilot randomized control study, recorded maternal voice played into preterm infant's incubator did not have any effect on maternal mental health.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3650487/

Maternal Voice and Short-Term Outcomes in Preterm Infants This study explored effects of exposure to maternal voice on short-term outcomes in very low birth weight preterm infants cared for within an neonatal intensive ...

7. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1673471/full

Listening to mom in the neonatal intensive care unit Recorded maternal speech in the NICU may also benefit sleep in preterm newborns, a factor relevant for brain development and which may have also been affected ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06839534

Effects of a Structured Maternal Voice Program on ... Findings indicate significant improvements in motor activity, sleep states, and maternal-infant attachment scores, supporting the integration of maternal voice ...