Actively Recruiting

Phase Not Applicable
Age: 1Week - 5Weeks
All Genders
ID05298748

Womb Recordings and Respiratory Control Maturation in Neonates

Led by Case Western Reserve University · Updated on 2025-12-05

34

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how early sound exposure affects brain development in preterm infants, focusing on the areas that control breathing. The study looks specifically at how womb-like sounds might help stabilize breathing patterns, reduce episodes of apnea, bradycardia, and low oxygen levels, and improve heart rate during a crucial stage of brain growth around 33-34 weeks gestation. Preterm infants born between 29 and 33 weeks gestational age, and who have reached 34 weeks corrected age without needing more than 1.5 liters per minute of respiratory support, will participate. They will be randomly assigned to hear alternating 6-hour blocks of either ambient noise or commercially available womb sound recordings over a 24-hour period, totaling 12 hours of each sound type. These womb recordings mimic the sounds experienced in the womb, including maternal heartbeats and other fetal sounds. During the 24-hour study period, researchers will monitor breathing and heart function, tracking events like pauses in breathing, heart rate changes, and body movement. This will help measure the immediate effects of the sound exposure on respiratory control. The study will continue until November 2026, with participants monitored closely during the intervention.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Week - 5Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born between 29 and 33 weeks gestational age
  • Currently at 34 weeks corrected age
  • Off respiratory support greater than 1.5 liters per minute
Not Eligible

You will not qualify if you...

  • Receiving respiratory support greater than 1.5 liters per minute
  • Presence of congenital anomalies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 hours

Participants are exposed to alternating 6-hour periods of womb sound recordings and ambient noise over a 24-hour period to assess effects on respiratory control maturation.

1 continuous exposure session lasting 24 hours

Trial Site Locations

Total: 1 location

1

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106-7061

Actively Recruiting

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Research Team

C

Cynthia Bearer, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Effects of brief, clustered versus dispersed hypoxic episodes on systemic and ocular growth factors in a rat model of oxygen-induced retinopathy.

Rebecca J Coleman, Kay D A Beharry, Romy S Brock...

https://pubmed.ncbi.nlm.nih.gov/18344903

Music therapy and retinopathy of prematurity screening: using recorded maternal singing and heartbeat for post exam recovery.

Maxwell J Corrigan, Jason R Keeler, Harriet D Miller...

https://pubmed.ncbi.nlm.nih.gov/32681063