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| ID | Type | Description | Link |
|---|---|---|---|
| 1K99HD084749-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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. 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Language Treatment Arm | Experimental | An infant participant randomized to the language treatment arm will be played recordings of his/her mother's voice 2-3 hours daily in the intermediate care nursery until discharge. |
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| Control Treatment Arm | Sham Comparator | An infant participant randomized to the control treatment arm will receive standard of care. Standard of care does not include being played recordings of his/her mother's voice while admitted to the intermediate care nursery. However, an infant randomized to the control treatment will have the same auditory equipment placed in his/her isolette or crib as an infant randomized to the Language Treatment Arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Language Treatment | Behavioral | Recording of a mother's voice reading a children's storybook. |
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| Measure | Description | Time Frame |
|---|---|---|
| White matter mean diffusivity | Mean diffusivity measures the average rate of water diffusion within a given MRI voxel. | 36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Days in hospital since birth and until discharge | Days in hospital since birth and until discharge, average range is 37-40 weeks postmenstrual age (PMA) |
| Average daily weight gain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine E Travis, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University - Lucile Packard Children's Hospital | Palo Alto | California | 94304 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2020 | Oct 27, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Control Treatment | Behavioral | Standard of Care |
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| 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 | measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA |
| 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 |