Mother's Voice Therapy for Premature Birth

Overseen By Edith Brignoni-Perez, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Congenital anomalies, Seizure disorders, Hydrocephalus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: Until hospital discharge, approximately 37-40 weeks PMA

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if recordings of a mother's voice can promote healthy brain and language development in preterm infants. Babies in the study will either listen to their mother's voice daily (Language Treatment) or receive standard care without the recordings (Control Treatment). The trial is designed for preterm infants born between 24 and 31 weeks at Stanford Children's Hospital, excluding those with certain medical conditions like major hearing loss or active seizures.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance early developmental care for preterm infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that playing a mother's voice is safe for infants?

Research has shown that listening to a mother's voice is generally safe for premature babies. It helps maintain a steady heart rate and supports weight gain, indicating good tolerance. Other studies have found that playing recordings of a mother's voice can enhance brain development in premature babies. Although results have varied regarding effects on areas like feeding and cognitive skills, no major safety concerns have been reported. Overall, mother's voice therapy appears to be a safe option for these infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mother's Voice Therapy because it takes a unique approach to supporting premature infants. Unlike traditional treatments that focus on medical interventions and environmental modifications, this therapy uses recordings of a mother's voice to potentially enhance language and cognitive development. The therapy is non-invasive, aiming to create a comforting and familiar auditory environment that might help with brain development at a critical time. By leveraging the natural bond between mother and child, this method could offer a simple yet powerful tool to improve outcomes for premature babies.

What evidence suggests that playing a mother's voice is effective for promoting brain and language development in preterm infants?

This trial will compare the effects of playing recordings of a mother's voice with standard care for premature infants. Studies have shown that hearing a mother's voice aids in developing language skills in a premature baby's brain. Research indicates that listening to a mother's voice can stabilize preterm infants by improving heart rate and reducing breathing problems. Babies who hear their mother's voice also tend to develop better language skills. Additionally, a mother's voice can reduce pain and improve body functions in newborns. These findings suggest that playing recordings of a mother's voice could support healthy brain and language development in preterm infants. ^{1 4 5 6 7}

Who Is on the Research Team?

Katherine E Travis, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for premature infants born at Stanford Children's Hospital between 24 and nearly 32 weeks of gestation. It excludes those with congenital anomalies, seizure disorders, severe brain injuries like grade III-IV hemorrhages or cystic PVL, major hearing loss, or conditions requiring transfer before reaching 36 weeks post-menstrual age.

Inclusion Criteria

My baby was born prematurely at Stanford Children's Hospital between 24 and 31 weeks.

Exclusion Criteria

I had surgery for a severe intestinal condition.

My baby is likely to leave the NICU before 36 weeks of age and/or needs a brain MRI.

I have seizures that are currently not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants are played recordings of their mother's voice 2-3 hours daily in the intermediate care nursery until discharge

Until hospital discharge, approximately 37-40 weeks PMA

Follow-up

Participants are monitored for long-term impacts on brain and language development, including MRI scans and language assessments

12 to 18 months

Follow-up visits at 12 and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Control Treatment
• Language Treatment

Trial Overview The study tests if playing a mother's voice recordings to preterm infants in the nursery can help their brain and language development. Infants will receive either this language treatment or a control treatment without the recordings.

How Is the Trial Designed?

Group I: Language Treatment Arm Experimental Treatment 1 Intervention

An infant participant randomized to the language treatment arm will be played recordings of his/her mother's voice 2-3 hours daily in the intermediate care nursery until discharge.

Group II: Control Treatment Arm Placebo Group 1 Intervention

An infant participant randomized to the control treatment arm will receive standard of care. Standard of care does not include being played recordings of his/her mother's voice while admitted to the intermediate care nursery. However, an infant randomized to the control treatment will have the same auditory equipment placed in his/her isolette or crib as an infant randomized to the Language Treatment Arm.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

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

Mom's voice boosts language-center development in ... Hearing the sound of their mother's voice promotes development of language pathways in a premature baby's brain, according to a new Stanford ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02847689

NCT02847689 | Listening to Mom in the NICU: Neural, ... The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10036054/

Maternal voice reduces procedural pain in neonates Maternal voice is beneficial to reduce procedural pain and improve the physiological indicators in neonates.

4. withpower.com withpower.com/trial/mothers-voice-therapy-for-premature-birth-317bd

Mother's Voice Therapy for Premature Birth Research shows that listening to a mother's voice can help stabilize preterm infants, improving their heart rate and reducing breathing problems. It also ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2950541025000183

Parents' Speech in the NICU and Language Development ... Involving parents in the neonatal care of their preterm infants may enhance better language development outcomes. A study by Caskey et al has found a positive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8276502/

effects of increased maternal speech exposure on language ... Infants born very preterm (< 32 weeks gestational age (GA)) are at risk for developmental language delays. Poor language outcomes in ...

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

Effects of maternal singing or voice on language and social ... Systematic reviews have shown conflicting effects of maternal voice exposure on premature infants' physiological parameters, oral feeding and preterm cognitive ...