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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambient noise followed by Womb sound | Other | 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. |
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| Womb sound recordings followed by ambient noise | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Womb sound recordings | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Bearer, MD | Contact | 216 844-3387 | Cynthia.Bearer@UHhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Cynthia Bearer, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106-7061 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9836852 | Background | Noise: a hazard for the fetus and newborn. American Academy of Pediatrics. Committee on Environmental Health. Pediatrics. 1997 Oct;100(4):724-7. No abstract available. | |
| 33811871 | Background | Jobe AH, Bancalari E. An All-Inclusive Perspective on Bronchopulmonary Dysplasia. J Pediatr. 2021 Jul;234:257-259. doi: 10.1016/j.jpeds.2021.03.063. Epub 2021 Apr 1. No abstract available. |
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| ID | Term |
|---|---|
| D001049 | Apnea |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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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.
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The order of the sound exposure will be randomized within each subject. The outcomes assessor (quantifying cardiorespiratory events) will be blinded as to the order of the 6 hour randomization blocks within the 24 hour study.
|
| 23536026 | Background | White RD, Smith JA, Shepley MM; Committee to Establish Recommended Standards for Newborn ICU Design. Recommended standards for newborn ICU design, eighth edition. J Perinatol. 2013 Apr;33 Suppl 1:S2-16. doi: 10.1038/jp.2013.10. |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |