Идёт набор NCT07699536

Prenatal Music Exposure to Enhance Postnatal Language Development

Без фазы С лечением Pregnancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: High dose music Exposure, Education, Low dose music exposure.
Кому может быть актуально: Состояния в реестре: Pregnancy. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай, Гонконг
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

\[BACKGROUND\] 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.

Вмешательства

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

Первичные конечные точки

Neural encoding of speech as measured by EEG [Срок оценки: Birth to 1 month, and at 6, 12, and 24 months of age]

Вторичные конечные точки (2)

Chinese Communicative Development Inventories (CCDI) [Срок оценки: 12, and 24 months old]
Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4) [Срок оценки: 6, 12, and 24 months old]

Критерии участия

Критерии включения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да