Effects of Mother's Voice and Heartbeat Sounds on Preterm Newborns

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Exposure to Biological Maternal Sounds in Extremely Preterm Infants: Effects on Short- and Long-term Outcomes

Conditions
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Preterm Birth

Intervention / Treatment
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* Other: Biological Maternal Sounds


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological Maternal Sounds<br>Daily Exposure to recorded mother's voice and heartbeat sounds via audio systems installed at the bedside | Other: Biological Maternal Sounds<br> <br> |
| Sham Comparator: Hospital Sounds<br>Exposure to standard hospital sounds; routine care. | Other: Biological Maternal Sounds<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal care, preterm, maternal sounds, auditory stimulation