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NCT05298748NARecruiting

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

Case Western Reserve University

Start Date

9/16/2022

Completion Date

11/1/2026

Summary

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

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

OTHER

Womb sound recordings

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Conditions

Apnea of PrematurityIntermittent HypoxemiaBradycardia

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106-7061

United States