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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
[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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Peggy Chan, PhD
- Número de telefone: +852 3943 9443
- E-mail: peggy.chan@cuhk.edu.hk
Locais de estudo
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Shenzhen, China
- Recrutamento
- BaoAn Hospital
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Contato:
- Peggy Chan, PhD
- Número de telefone: +852 39439443
- E-mail: peggy.chan@cuhk.edu.hk
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Investigador principal:
- B Sun, MD
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Investigador principal:
- Q Shi, MD
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Investigador principal:
- H Wang, MD
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Subinvestigador:
- XH Wei, MD
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Hong Kong, Hong Kong
- Recrutamento
- The Prince of Wales Hospital
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Contato:
- Peggy Chan, PhD
- Número de telefone: +852 39439443
- E-mail: peggy.chan@cuhk.edu.hk
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Investigador principal:
- HS Lam, MD
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Investigador principal:
- CWW Chu, MD
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Investigador principal:
- TY Leung, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: High-dose music
Participants will be exposed to a higher dose of music
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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.
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Comparador Ativo: Low-dose music
Participants will be exposed to a lower dose of music
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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.
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Comparador de Placebo: Education
Participants will learn independently from educational materials
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Participants will learn independently from short educational videos and audios on pregnancy, maternal and child health, and parenting, five days a week.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Neural encoding of speech as measured by EEG
Prazo: Birth to 1 month, and at 6, 12, and 24 months of age
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Comparing the ability of neural encoding of speech as measured by EEG between groups.
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Birth to 1 month, and at 6, 12, and 24 months of age
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Chinese Communicative Development Inventories (CCDI)
Prazo: 12, and 24 months old
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Comparing language and communicative abilities, as measured by the Chinese Communicative Development Inventories (CCDI), between groups.
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12, and 24 months old
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Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4)
Prazo: 6, 12, and 24 months old
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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.
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6, 12, and 24 months old
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Change from baseline in stress score on the Perceived Stress Scale (PSS)
Prazo: From recruitment to 24 months old
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PSS stress score ranges from 0 to 40, with higher scores indicating higher perceived stress.
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From recruitment to 24 months old
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Change from baseline in depression score on the Edinburgh Postnatal Depression Scale (EPDS)
Prazo: From recruitment to 12 months old
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The depression score ranges from 0 to 30, with a higher score indicating a high likelihood of depression.
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From recruitment to 12 months old
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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
Prazo: Recruitment and birth to 1 month old
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Total correct score ranges from 0- 20
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Recruitment and birth to 1 month old
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Maternal sleep behavior measured by the Pittsburgh Sleep Quality Index (PSQI)
Prazo: From recruitment to 24 months old
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From recruitment to 24 months old
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Brief Infant Sleep Questionnaire (BISQ)
Prazo: 6, 12, and 24 months old
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6, 12, and 24 months old
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Child development, emotion, and behavior measured by the Survey of Well-being of Young Children (SWYC)
Prazo: 6, 12, and 24 months old
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6, 12, and 24 months old
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Mother-infant attachment measured by the Postpartum Bonding Questionnaire (PBQ)
Prazo: 0-1months, 6, and 12 months old
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The PBQ score ranges from 0 to 125; the higher scores mean a poorer outcome.
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0-1months, 6, and 12 months old
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- C4055-19GF
- 2023.354 (Outro identificador: Joint CUHK-NTEC Clinical Research Ethics Committee)
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