The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants

Study Overview
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Brief Summary
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The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.

Detailed Description
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The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants. We hypothesize that exposure to appropriately designed womb-like sounds in the Neonatal Intensive Care Unit (NICU) will induce a more mature and stabilized cardiorespiratory pattern manifesting as a decrease in apnea, bradycardia, intermittent hypoxemia and mean heart rate. This proposal lays the foundation for further development of actual womb and maternal voice recordings containing components that closely mimic the womb environment during 33-34 weeks of gestation, a proposed therapeutic window of brain development. These sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce maturation of neuronal respiratory networks during this critical stage of development.

Official Title
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Womb Recordings and Respiratory Control Maturation in Neonates

Conditions
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Apnea of Prematurity, Intermittent Hypoxemia, Bradycardia

Intervention / Treatment
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* Other: Womb sound recordings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm infants 29-33 weeks gestational age at birth 34 weeks corrected age off respiratory support >1.5 lpm Exclusion Criteria: on respiratory support >1.5 lpm congenital anomalies

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 5 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single site, single visit study. The order of exposure, two 6 hour periods of ambient noise and two 6 hour periods of sound, will be randomized within each subject for a total of 24hrs of sound exposure.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ambient noise followed by Womb sound<br>At 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of ambient noise followed by commercially available womb sounds over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise. | Other: Womb sound recordings<br>* Womb sounds will be chosen from commercially available (Amazon) womb recordings using a recording that most closely resembles the womb including maternal heart rate, fetal heartbeat, respiratory sounds, bowel popping sounds and frequency spectra as described by Parga, Daland 2018 et al.<br>|
| Other: Womb sound recordings followed by ambient noise<br>At 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of commercially available womb sounds followed by ambient noise over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise. | Other: Womb sound recordings<br>* Womb sounds will be chosen from commercially available (Amazon) womb recordings using a recording that most closely resembles the womb including maternal heart rate, fetal heartbeat, respiratory sounds, bowel popping sounds and frequency spectra as described by Parga, Daland 2018 et al.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiorespiratory events | Apnea (>20 seconds or shorter with intermittent hypoxemia <85% or bradycardia <80bpm) | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | 
| intermittent hypoxemia | falls in oxygen saturation <85% | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | 
| mean heart rate | mean heart rate | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | 
| bradycardia | heart rate <80bpm | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | 
| body motion | non-cardiac alterations in the oximeter plethysmograph waveform | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | 
| respiratory pauses | Respiratory pauses of >5sec will be documented to increase the chance of capturing small alterations in respiratory stability. | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apnea, intermittent hypoxemia, bradycardia, audio recording