NCT05298748RecruitingNot Applicable

Womb Recordings and Respiratory Control Maturation in Neonates

Case Western Reserve University2 sites in 1 country34 target enrollmentStarted: September 16, 2022Last updated: December 5, 2025

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor: Case Western Reserve University
Enrollment: 34
Locations: 2
Primary Endpoint: mean heart rate

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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 Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group
Primary Purpose: Prevention
Masking: Single (Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages: 1 Week to 5 Weeks (Child)
Sex: All
Accepts Healthy Volunteers: No

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

Arms & Interventions

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.

Intervention: Womb sound recordings (Other)

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.

Intervention: Womb sound recordings (Other)