Premature Birth
Conditions
Keywords
Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALLanguage Treatment
Recording of a mother's voice reading a children's storybook.
BEHAVIORALControl Treatment
Standard of Care
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 31 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants born preterm at Stanford Children's Hospital between 24 0/7 - 31 6/7 weeks gestational age
Exclusion criteria
* Congenital anomalies * Recognizable malformation syndromes * Active seizure disorders * History of Central Nervous System infections * Hydrocephalus * Major sensori-neural hearing loss * Likelihood to be transferred from NICU to alternate care facility or home environment prior to 36 weeks PMA and/or brain MRI scan * Intraventricular Hemorrhage Grades III-IV * Cystic periventricular leukomalacia (PVL) * Surgical treatment for necrotizing enterocolitis * Small for gestational age (SGA) \<3 percentile and/or Intra-uterine growth restriction (IUGR) no head sparing * Twin-to-twin transfusions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard and Raw Scores of Receptive and Expressive Language on MacArthur-Bates Communicative Development Inventory (CDI): Words and Sentences | 18 month follow-up adjusted age for preterm birth | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fractional Anisotropy of white matter tracts of the brain | Assessed at near-term equivalent age MRI scan (approx. 36-37 weeks postmenstrual age) or at time of hospital discharge, whichever comes first | Diffusion MRI metric that measures the directionality of water diffusion in the brain. It is used to assess white matter development and structure. |
| Score on MacArthur-Bates Communicative Development Inventories: Words and Gestures | 12 month follow-up adjusted for preterm birth | 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. |
| White matter mean diffusivity | Assessed at near-term equivalent age MRI scan (approx. 36-37 weeks postmenstrual age) or at time of hospital discharge, whichever comes first | Diffusion MRI metric that measures the average rate of water diffusion. It is used to assess white matter development and structure. |
| Time (days) to full oral feed | measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA | days until 100 % of nutrition administered orally |
| Average daily weight gain | measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA | measured as weight gain per day |
| Number of significant apnea, bradycardia and desaturation events requiring stimulation | measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA | Reflects degree of cardiorespiratory stability |
Countries
United States
Outcome results
None listed