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NCT Number: NCT07699536

Prenatal Music Exposure to Enhance Postnatal Language Development

The goal of this randomized controlled study is to evaluate the effect of prenatal music exposure on infants through two years of age.

The study addresses two primary questions:

* Whether prenatal music exposure enhances neural encoding of speech and improve language and cognitive outcomes during the first two years of life among fetuses * Whether predictive models can be developed from available fetal data to forecast individual differences in developmental outcomes among fetuses exposed to prenatal music.

Participants will engage in music listening or self-learning five days a week until delivery. After the participants give birth, the children will be followed up on their neural responses to speech, as well as their language and cognitive development, until they reach two years of age.

The investigators will compare the effects of low- and high-dose prenatal music exposure with a control group receiving education and develop models to predict outcomes in fetuses exposed to prenatal music.

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Key information

Conditions

Pregnancy Behavior Communication Language

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BaoAn Hospital, Shenzhen, China

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About this study

[BACKGROUND] Fetuses can hear in the womb from as early as 20 weeks of gestation. Research has shown that prenatal music and spoken language experiences are related to better neural and behavioral outcomes at birth. These findings, though focused on outcomes shortly after birth, are consistent with a larger body of research showing positive effects of postnatal music training on children's language and cognitive outcomes.

[AIM OF STUDY] Objective 1: To examine whether prenatal music exposure leads to better neural encoding of speech and better language and cognitive developmental outcomes up to two years of life.

Objective 2: To construct predictive models using fetal data (e.g., fetal brain MRI and ultrasound data, if available) to forecast individual differences in developmental outcomes among fetuses exposed to prenatal music.

[HYPOTHESIS] The investigators hypothesize that prenatal music exposure can strengthen a fetus's neural encoding of speech from birth, leading to better language and cognitive development in early childhood. The investigators further hypothesize that, despite the expected heterogeneity in intervention effects, fetal features can predict how much a fetus would benefit from prenatal music exposure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • residents of the Greater Bay Area (GBA) with Cantonese and/or Putonghua being the primary home language(s)
  • aged 18 years or above
  • single fetus pregnancy
  • Less than 32 weeks of gestation

Treatment and study plan

High dose music Exposure

Other

Participants will be exposed to children's songs in various languages for 40 minutes daily, five days per week, with 80% of songs presented at approximately 75 dB SPL and 20% at approximately 10 dB SPL.

Education

Other

Participants will learn independently from short educational videos and audios on pregnancy, maternal and child health, and parenting, five days a week.

Low dose music exposure

Other

Participants will be exposed to children's songs in various languages for 15 minutes daily, five days per week, with 20% of songs presented at approximately 75 dB SPL and 80% at approximately 10 dB SPL.

Primary outcomes

  1. Neural encoding of speech as measured by EEG

    Time frame: Birth to 1 month, and at 6, 12, and 24 months of age

    Comparing the ability of neural encoding of speech as measured by EEG between groups.

Secondary outcomes

  1. Chinese Communicative Development Inventories (CCDI)

    Time frame: 12, and 24 months old

    Comparing language and communicative abilities, as measured by the Chinese Communicative Development Inventories (CCDI), between groups.

  2. Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4)

    Time frame: 6, 12, and 24 months old

    Five developmental domains (and subdomains): Cognitive, Language (Receptive and Expressive Communication subdomains), Motor (fine and gross motor subdomains), Social-emotional, and Adaptive Behavior will be assessed and compared across groups. The domain standard scores range from 45-155, and the subdomain scaled scores range from 1- 19 . Higher scores indicate better outcomes.

Other outcomes

  1. Change from baseline in stress score on the Perceived Stress Scale (PSS)

    Time frame: From recruitment to 24 months old

    PSS stress score ranges from 0 to 40, with higher scores indicating higher perceived stress.

  2. Change from baseline in depression score on the Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: From recruitment to 12 months old

    The depression score ranges from 0 to 30, with a higher score indicating a high likelihood of depression.

  3. Change from baseline in maternal knowledge of child development on the 20-item short form of the Knowledge of Infant Development Inventory (KIDI) across groups

    Time frame: Recruitment and birth to 1 month old

    Total correct score ranges from 0- 20

  4. Maternal sleep behavior measured by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: From recruitment to 24 months old

  5. Brief Infant Sleep Questionnaire (BISQ)

    Time frame: 6, 12, and 24 months old

  6. Child development, emotion, and behavior measured by the Survey of Well-being of Young Children (SWYC)

    Time frame: 6, 12, and 24 months old

  7. Mother-infant attachment measured by the Postpartum Bonding Questionnaire (PBQ)

    Time frame: 0-1months, 6, and 12 months old

    The PBQ score ranges from 0 to 125; the higher scores mean a poorer outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Peggy Chan, PhD

CONTACT

[email protected]

+852 3943 9443

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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