Exposure to Biological Maternal Sounds in Extremely Preterm Infants: Effects on Short- and Long-term Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Brain volume (DM^3)
- Last Updated
- 12 years ago
Overview
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.
Investigators
Amir Lahav
Instructor in Pediatrics
Brigham and Women's Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Brain volume (DM^3)
Time Frame: 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
Time Frame: 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 Outcomes
- Oxygen saturation levels (mg/l)(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Heart rate (BPM)(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Infant vocalization (word count)(Between 32-36 weeks gesation)
- Weight gain (gr/kg/day)(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)