The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.
Children born preterm are at-risk for developmental language delays. Language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. There is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development. Participants will be randomly assigned to one of two study groups. Each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. Mother's of participating infants will have her voice recorded as she reads a common children's storybook. Recordings will be played to infants each day until s/he is discharged from the hospital. To assess the long term impacts of this treatment, research participants and their families will be asked to return for follow-up visiting to perform an MRI brain scan and complete questionnaires and test that assess language development. Follow-up visit occur when infants are between 12 to 18 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
57
Recording of a mother's voice reading a children's storybook.
Standard of Care
Stanford University - Lucile Packard Children's Hospital
Palo Alto, California, United States
Standard and Raw Scores of Receptive and Expressive Language on MacArthur-Bates Communicative Development Inventory (CDI): Words and Sentences
Parent questionnaire of receptive and expressive language skills. Will be used to assess the long-term impact of intervention on language outcomes. Standard scores are based on percentiles for age and sex and range from \<1 to 99th percentile. Raw scores range from 0 to 680. Both higher standard scores and raw scores indicate better performance.
Time frame: 18 month follow-up adjusted age for preterm birth
White matter mean diffusivity
Diffusion MRI metric that measures the average rate of water diffusion. It is used to assess white matter development and structure.
Time frame: Assessed at near-term equivalent age MRI scan (approx. 36-37 weeks postmenstrual age) or at time of hospital discharge, whichever comes first
Fractional Anisotropy of white matter tracts of the brain
Diffusion MRI metric that measures the directionality of water diffusion in the brain. It is used to assess white matter development and structure.
Time frame: Assessed at near-term equivalent age MRI scan (approx. 36-37 weeks postmenstrual age) or at time of hospital discharge, whichever comes first
White matter mean diffusivity
Diffusion MRI metric that measures the average rate of water diffusion. It is used to assess white matter development and structure
Time frame: Assessed at 12 month follow-up MRI
Fractional Anisotropy of white matter tracts of the brain
Diffusion MRI metric that measures the directionality of water diffusion in the brain. It is used to assess white matter development and structure.
Time frame: Assessed at 12 month follow-up MRI
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Score on MacArthur-Bates Communicative Development Inventories: Words and Gestures
Parent questionnaire of receptive and expressive language skills. Will be used to assess the long-term impact of intervention on language outcomes. Standard scores are based on percentiles for age and sex and range from \<1 to 99th percentile. Raw scores range from 0 to 396. Both higher standard scores and raw scores indicate better performance.
Time frame: 12 month follow-up adjusted for preterm birth
Number of significant apnea, bradycardia and desaturation events requiring stimulation
Reflects degree of cardiorespiratory stability
Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Time (days) to full oral feed
days until 100 % of nutrition administered orally
Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Average daily weight gain
measured as weight gain per day
Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA