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| Name | Class |
|---|---|
| Charles H. Hood Foundation | OTHER |
| Peter and Elizabeth C. Tower Foundation | UNKNOWN |
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The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory stability and early vocalization during postnatal development. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental in premature infants and will increase their potential to grow into healthy children.
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal auditory stimulation can influence physical growth, brain maturation, respiratory stability (including heart rate, respiratory rate and oxygen saturation levels) as well as early vocalization prior to 40 weeks gestation. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental outcomes in premature infants and will increase their potential to grow into healthy children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological Maternal Sounds | Experimental | Daily Exposure to recorded mother's voice and heartbeat sounds via audio systems installed at the bedside |
|
| Hospital Sounds | Sham Comparator | Exposure to standard hospital sounds; routine care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological Maternal Sounds | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain volume (DM^3) | Data will be obtained by an MRI brain scan and will be calculated separately for white matter, grey matter, CSF. | Between 36-40 weeks gestation |
| Language and cognitive skills | Data will be obtained using the MacArthur-Bates Communicative Development Inventories (CDI), the Receptive-Expressive Emergent Language Test Third Edition (REEL-3), and the Bayley Scales of Infant Development Third Edition (Bayley-III). | At 12 and 24 months corrected-age |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation levels (mg/l) | Data will be collected from the bedside cardiac monitor | participants will be followed for the duration of hospital stay, an expected average of 6 weeks |
| Heart rate (BPM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir Lahav, ScD | Contact | amir@hms.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amir Lahav, ScD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Data will be collected from the bedside cardiac monitor
| participants will be followed for the duration of hospital stay, an expected average of 6 weeks |
| Infant vocalization (word count) | Data will be obtained by real-time recording of the language environment | Between 32-36 weeks gesation |
| Weight gain (gr/kg/day) | Data will be obtained from medical records | participants will be followed for the duration of hospital stay, an expected average of 6 weeks |
| D000091642 | Urogenital Diseases |