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

57 Participants Needed

Trial Summary

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 data supports the effectiveness of 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 supports better feeding and language development in these infants. ^{1 2 3 4 5}

Is Mother's Voice Therapy safe for premature infants?

Research shows that listening to a mother's voice is generally safe for premature infants. It can help stabilize their heart rate and improve weight gain, with no reported harmful effects. ^{1 2 3 6 7}

How does Mother's Voice Therapy differ from other treatments for premature infants?

Mother's Voice Therapy is unique because it involves using the mother's voice, either live or recorded, to help stabilize preterm infants by reducing cardiorespiratory events and potentially improving feeding and growth. Unlike other treatments, it also benefits mothers by increasing oxytocin levels, which can reduce anxiety and enhance their caregiving abilities. ^{1 2 3 8 9}

What is the purpose of this trial?

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 promoting healthy brain and language development in infants born preterm.

Research Team

Katherine E Travis, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Norway pubmed.ncbi.nlm.nih.gov

Systematic review of maternal voice interventions demonstrates increased stability in preterm infants. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of recorded maternal voice on anthropometric parameters and heart rate in premature infants: A pilot randomised controlled trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of maternal voice on proportion of oral feeding in preterm infants. [2023]

4. Norway pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of maternal infant-directed reading among hospitalised preterm infants. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Factors influencing language development in preterm infants. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

[Clinical and electrophysiological effects of auditive stimulation in preterm neonates]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Controlled Trial of Behavioral Voice Therapy for Dysphonia Related to Prematurity of Birth. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Oxytocin Levels Increase and Anxiety Decreases in Mothers Who Sing and Talk to Their Premature Infants during a Painful Procedure. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Functional hoarseness in children: short-term play therapy with family dynamic counseling as therapy of choice. [2013]