Prenatal Music Exposure to Enhance Postnatal Language Development
ConditionPregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
High dose music Exposure
Other interventionParticipants 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.
Education
Other interventionParticipants will learn independently from short educational videos and audios on pregnancy, maternal and child health, and parenting, five days a week.
Low dose music exposure
Other interventionParticipants 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.
Treatment groups
480 Participants
are divided into 3 treatment groupsGroup A: High-dose musicExperimental treatment 1 intervention
Group B: Low-dose musicActive comparator 1 intervention
Group C: EducationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neural encoding of speech as measured by EEG
Comparing the ability of neural encoding of speech as measured by EEG between groups.
Time frame
Birth to 1 month, and at 6, 12, and 24 months of ageSecondary outcomes
1
Chinese Communicative Development Inventories (CCDI)
Comparing language and communicative abilities, as measured by the Chinese Communicative Development Inventories (CCDI), between groups.
Time frame
12, and 24 months old2
Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4)
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.
Time frame
6, 12, and 24 months oldOther outcomes
1
Change from baseline in stress score on the Perceived Stress Scale (PSS)
PSS stress score ranges from 0 to 40, with higher scores indicating higher perceived stress.
Time frame
From recruitment to 24 months old2
Change from baseline in depression score on the Edinburgh Postnatal Depression Scale (EPDS)
The depression score ranges from 0 to 30, with a higher score indicating a high likelihood of depression.
Time frame
From recruitment to 12 months old3
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
Total correct score ranges from 0- 20
Time frame
Recruitment and birth to 1 month old4
Maternal sleep behavior measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame
From recruitment to 24 months oldSponsors and contacts
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Source ClinicalTrials.gov