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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
[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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Peggy Chan, PhD
- Número de teléfono: +852 3943 9443
- Correo electrónico: peggy.chan@cuhk.edu.hk
Ubicaciones de estudio
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Hong Kong, Hong Kong
- Reclutamiento
- The Prince of Wales Hospital
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Contacto:
- Peggy Chan, PhD
- Número de teléfono: +852 39439443
- Correo electrónico: 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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Shenzhen, Porcelana
- Reclutamiento
- BaoAn Hospital
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Contacto:
- Peggy Chan, PhD
- Número de teléfono: +852 39439443
- Correo electrónico: 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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Sub-Investigador:
- XH Wei, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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 activo: 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 placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Neural encoding of speech as measured by EEG
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Chinese Communicative Development Inventories (CCDI)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in stress score on the Perceived Stress Scale (PSS)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C4055-19GF
- 2023.354 (Otro identificador: Joint CUHK-NTEC Clinical Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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