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.
調査の概要
詳細な説明
[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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Peggy Chan, PhD
- 電話番号：+852 3943 9443
- メール：peggy.chan@cuhk.edu.hk
研究場所
-
-
-
Shenzhen、中国
- 募集
- BaoAn Hospital
-
コンタクト：
- Peggy Chan, PhD
- 電話番号：+852 39439443
- メール：peggy.chan@cuhk.edu.hk
-
主任研究者：
- B Sun, MD
-
主任研究者：
- Q Shi, MD
-
主任研究者：
- H Wang, MD
-
副調査官：
- XH Wei, MD
-
-
-
-
-
Hong Kong、香港
- 募集
- The Prince of Wales Hospital
-
コンタクト：
- Peggy Chan, PhD
- 電話番号：+852 39439443
- メール：peggy.chan@cuhk.edu.hk
-
主任研究者：
- HS Lam, MD
-
主任研究者：
- CWW Chu, MD
-
主任研究者：
- TY Leung, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：High-dose music
Participants will be exposed to a higher dose of music
|
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.
|
|
アクティブコンパレータ：Low-dose music
Participants will be exposed to a lower dose of music
|
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.
|
|
プラセボコンパレーター：Education
Participants will learn independently from educational materials
|
Participants will learn independently from short educational videos and audios on pregnancy, maternal and child health, and parenting, five days a week.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neural encoding of speech as measured by EEG
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Chinese Communicative Development Inventories (CCDI)
時間枠：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)
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in stress score on the Perceived Stress Scale (PSS)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：From recruitment to 24 months old
|
From recruitment to 24 months old
|
|
|
Brief Infant Sleep Questionnaire (BISQ)
時間枠：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)
時間枠：6, 12, and 24 months old
|
6, 12, and 24 months old
|
|
|
Mother-infant attachment measured by the Postpartum Bonding Questionnaire (PBQ)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- C4055-19GF
- 2023.354 (その他の識別子：Joint CUHK-NTEC Clinical Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。