Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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https://pubmed.ncbi.nlm.nih.gov/12524574