NCT05298748 · Case Western Reserve University
The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants
What this study is about
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.
View original scientific 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.
Interventions
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.
Primary outcome measures
cardiorespiratory events
Time frame: 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
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
falls in oxygen saturation \<85%
mean heart rate
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
mean heart rate
bradycardia
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
heart rate \<80bpm
body motion
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
non-cardiac alterations in the oximeter plethysmograph waveform
respiratory pauses
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Cleveland, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations