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. Participation in this study requires that all infants receive up to an additional 10 minutes of brain scans as part of his/her routine clinical magnetic resonance imaging (MRI).
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 27 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 * 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 |
|---|---|---|
| White matter mean diffusivity | 36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first | Mean diffusivity measures the average rate of water diffusion within a given MRI voxel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Days in hospital since birth and until discharge, average range is 37-40 weeks postmenstrual age (PMA) | Days in hospital since birth and until discharge |
| Average daily weight gain | measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA | — |
| 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 |
| Number of significant apnea and bradycardia events requiring stimulation | measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA | — |
Countries
United States
Outcome results
None listed