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Mother's Voice Therapy for Premature Birth

N/A
Waitlist Available
Led By Katherine E Travis, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants born preterm at Stanford Children's Hospital between 24 0/7 - 31 6/7 weeks gestational age
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 month follow-up adjusted age for preterm birth
Awards & highlights

Study Summary

This trial will test whether hearing their mother's voice can help preterm babies develop normally.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves non-invasive audio recordings, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born prematurely at Stanford Children's Hospital between 24 and 31 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 month follow-up adjusted age for preterm birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 month follow-up adjusted age for preterm birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Standard and Raw Scores of Receptive and Expressive Language on MacArthur-Bates Communicative Development Inventory (CDI): Words and Sentences
Secondary outcome measures
Average daily weight gain
Fractional Anisotropy of white matter tracts of the brain
Number of significant apnea, bradycardia and desaturation events requiring stimulation
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Language Treatment ArmExperimental Treatment1 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 ArmPlacebo Group1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Language Treatment
2016
N/A
~50

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,870 Total Patients Enrolled
11 Trials studying Premature Birth
3,078 Patients Enrolled for Premature Birth
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,660,787 Total Patients Enrolled
64 Trials studying Premature Birth
119,336 Patients Enrolled for Premature Birth
Katherine E Travis, PhDPrincipal Investigator - Stanford University
Stanford University
1 Previous Clinical Trials
46 Total Patients Enrolled
1 Trials studying Premature Birth
46 Patients Enrolled for Premature Birth

Media Library

Language Treatment Clinical Trial Eligibility Overview. Trial Name: NCT04193579 — N/A
Language Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04193579 — N/A
Premature Birth Clinical Trial 2023: Language Treatment Highlights & Side Effects. Trial Name: NCT04193579 — N/A
Premature Birth Research Study Groups: Language Treatment Arm, Control Treatment Arm

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ideal demographic for participating in this research?

"This study is searching for 50 candidates who experienced a premature birth between 24 and 31 weeks gestation."

Answered by AI

Are septuagenarians applicable for this research protocol?

"This study is open to participants between the ages of 24 weeks and 31 weeks. For those older or younger than this age range, there are 185 trials for minors and 74 clinical studies for seniors over 65 available."

Answered by AI

How many volunteers are engaged in this experiment?

"Affirmative. The data presented on clinicaltrials.gov states that this research is recruiting participants as of now; it was initially published on November 25th, 2019 and the most recent update took place on May 3rd, 2022. A total of 50 patients are being sought out from 1 medical site for inclusion in the study."

Answered by AI

Are new participants being welcomed into this research currently?

"This experiment, which was originally made available on November 25th 2019, is currently in need of participants. Documentation hosted on clinicaltrials.gov shows that the trial has been recently updated as of May 3rd 2022."

Answered by AI
~13 spots leftby Aug 2025