NCT07699536

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
42mo left

Started Sep 2025

Longer than P75 for not_applicable pregnancy

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Apr 2030

Study Start

First participant enrolled

September 15, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

July 13, 2026

Status Verified

June 1, 2026

Enrollment Period

4.2 years

First QC Date

June 29, 2026

Last Update Submit

July 8, 2026

Conditions

Pregnancy

Keywords

Neural encodingPrenatal musicLanguageCognitiveEEGMusic exposurePregnancyPredictive model

Outcome Measures

Primary Outcomes (1)

  • Neural encoding of speech as measured by EEG

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

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

Secondary Outcomes (2)

  • Chinese Communicative Development Inventories (CCDI)

    12, and 24 months old

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

    6, 12, and 24 months old

Other Outcomes (7)

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

    From recruitment to 24 months old

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

    From recruitment to 12 months old

  • 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

    Recruitment and birth to 1 month old

  • +4 more other outcomes

Study Arms (3)

High-dose music

EXPERIMENTAL

Participants will be exposed to a higher dose of music

Other: High dose music Exposure

Low-dose music

ACTIVE COMPARATOR

Participants will be exposed to a lower dose of music

Other: Low dose music exposure

Education

PLACEBO COMPARATOR

Participants will learn independently from educational materials

Other: Education

Interventions

High dose music ExposureOTHER

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.

High-dose music
EducationOTHER

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

Education
Low dose music exposureOTHER

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.

Low-dose music

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant women are eligible
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BaoAn Hospital

Shenzhen, China

RECRUITING

The Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Language

Interventions

Educational Status

Condition Hierarchy (Ancestors)

CommunicationBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Peggy Chan, PhD

CONTACT

+852 3943 9443peggy.chan@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 13, 2026

Study Start

September 15, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

April 1, 2030

Last Updated

July 13, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)HK(1)