Preterm Birth
Conditions
Keywords
neonatal care, preterm, maternal sounds, auditory stimulation
Brief summary
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.
Detailed description
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.
Interventions
OTHERBiological Maternal Sounds
Sponsors
Charles H. Hood Foundation
Peter and Elizabeth C. Tower Foundation
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 34 Weeks
Healthy volunteers
No
Inclusion criteria
* Born between 24-36 weeks GA.
Exclusion criteria
* Chromosomal or congenital anomalies; congenital infections; \> grade II IVH; * maternal use of tobacco, alcohol, or illicit drugs; * significant abuse or malnutrition during pregnancy, * failed ABR. * No exclusions based on gender or ethnicity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain volume (DM^3) | Between 36-40 weeks gestation | Data will be obtained by an MRI brain scan and will be calculated separately for white matter, grey matter, CSF. |
| Language and cognitive skills | At 12 and 24 months corrected-age | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation levels (mg/l) | participants will be followed for the duration of hospital stay, an expected average of 6 weeks | Data will be collected from the bedside cardiac monitor |
| Heart rate (BPM) | participants will be followed for the duration of hospital stay, an expected average of 6 weeks | Data will be collected from the bedside cardiac monitor |
| Infant vocalization (word count) | Between 32-36 weeks gesation | Data will be obtained by real-time recording of the language environment |
| Weight gain (gr/kg/day) | participants will be followed for the duration of hospital stay, an expected average of 6 weeks | Data will be obtained from medical records |
Countries
United States
Contacts
Primary ContactAmir Lahav, ScD
Outcome results
None listed