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

Not Applicable

Recruiting

• Conditions: Intermittent Hypoxemia; Bradycardia; Apnea of Prematurity
• Interventions: Other: Womb sound recordings

• Registration Number: NCT05298748
• Lead Sponsor: Case Western Reserve University

Brief 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.

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-28
• Study Start: 2022-09-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Womb sound recordings followed by ambient noise	Womb sound recordings	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.
Ambient noise followed by Womb sound	Womb sound recordings	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States