NCT05298748

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

Womb Recordings and Respiratory Control Maturation in Neonates

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 1 Week – 5 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Apnea of Prematurity
• Intermittent Hypoxemia
• Bradycardia

Interventions

Type	Name	Description
OTHER	Womb sound recordings	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.

Timeline

• Start date: 2022-09-16
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2022-03-28
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States