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Prenatal Music Exposure to Enhance Postnatal Language Development

2026年7月8日 更新者：Patrick C. M. Wong、Chinese University of Hong Kong

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

[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.

研究类型

介入性

注册 (估计的)

480

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Shenzhen、中国
        • 招聘中
        • BaoAn Hospital
        • 接触：
        • 首席研究员：
          • B Sun, MD
        • 首席研究员：
          • Q Shi, MD
        • 首席研究员：
          • H Wang, MD
        • 副研究员：
          • XH Wei, MD
  • 香港
      • Hong Kong、香港
        • 招聘中
        • The Prince of Wales Hospital
        • 接触：
        • 首席研究员：
          • HS Lam, MD
        • 首席研究员：
          • CWW Chu, MD
        • 首席研究员：
          • TY Leung, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：High-dose music
Participants will be exposed to a higher dose of music
其他：High dose music Exposure
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.
有源比较器：Low-dose music
Participants will be exposed to a lower dose of music
其他：Low dose music exposure
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.
安慰剂比较：Education
Participants will learn independently from educational materials
其他：Education
Participants will learn independently from short educational videos and audios on pregnancy, maternal and child health, and parenting, five days a week.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Neural encoding of speech as measured by EEG
大体时间：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.
Birth to 1 month, and at 6, 12, and 24 months of age

次要结果测量

结果测量
措施说明
大体时间
Chinese Communicative Development Inventories (CCDI)
大体时间：12, and 24 months old
Comparing language and communicative abilities, as measured by the Chinese Communicative Development Inventories (CCDI), between groups.
12, and 24 months old
Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4)
大体时间：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.
6, 12, and 24 months old

其他结果措施

结果测量
措施说明
大体时间
Change from baseline in stress score on the Perceived Stress Scale (PSS)
大体时间：From recruitment to 24 months old
PSS stress score ranges from 0 to 40, with higher scores indicating higher perceived stress.
From recruitment to 24 months old
Change from baseline in depression score on the Edinburgh Postnatal Depression Scale (EPDS)
大体时间：From recruitment to 12 months old
The depression score ranges from 0 to 30, with a higher score indicating a high likelihood of depression.
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
大体时间：Recruitment and birth to 1 month old
Total correct score ranges from 0- 20
Recruitment and birth to 1 month old
Maternal sleep behavior measured by the Pittsburgh Sleep Quality Index (PSQI)
大体时间：From recruitment to 24 months old
From recruitment to 24 months old
Brief Infant Sleep Questionnaire (BISQ)
大体时间：6, 12, and 24 months old
6, 12, and 24 months old
Child development, emotion, and behavior measured by the Survey of Well-being of Young Children (SWYC)
大体时间：6, 12, and 24 months old
6, 12, and 24 months old
Mother-infant attachment measured by the Postpartum Bonding Questionnaire (PBQ)
大体时间：0-1months, 6, and 12 months old
The PBQ score ranges from 0 to 125; the higher scores mean a poorer outcome.
0-1months, 6, and 12 months old

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chinese University of Hong Kong

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月15日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2030年4月1日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年7月13日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • C4055-19GF
  • 2023.354 (其他标识符：Joint CUHK-NTEC Clinical Research Ethics Committee)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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