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Womb Recordings for Preterm Infant Breathing

This study is looking at how womb sound recordings might help preterm infants (babies born early) with breathing problems. Specifically, it's testing if listening to sounds like a mother's heartbeat and other womb noises can help stabilize their breathing patterns and reduce issues like apnea (pauses in breathing), bradycardia (slow heart rate), and intermittent hypoxemia (low oxygen levels). The study will include preterm infants who were born between 29-33 weeks gestation and are now around 34 weeks corrected age, and are not on significant breathing support. Researchers hope these sounds will help the brain areas that control breathing mature. The study plans to enroll 34 infants.

Study design
This is an interventional study, meaning participants will receive a specific intervention (womb sound recordings). It plans to enroll 34 participants.
What's involved
Participants will be exposed to randomized blocks of womb sound recordings and ambient noise over a 24-hour period.
Compensation
Not stated in the trial record.
Follow-up
Cardiorespiratory events, intermittent hypoxemia, and mean heart rate will be measured during the 24-hour period of the sound recordings.

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NCT05298748

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

Recruiting
NAAges 1–5InterventionalPrevention
Case Western Reserve University
~34 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:Womb sound recordings

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
cardiorespiratory events
Measured over During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
+5 more outcomes measured

Conditions

Apnea of Prematurity
Intermittent Hypoxemia
Bradycardia

Explore related trials

Apnea of PrematurityBradycardiaIntermittent hypothermia

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Cynthia Bearer, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center

Who to contact

Cynthia Bearer, MD
[email protected]
216 844-3387
Email the study team

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Eligibility criteria

Inclusion

preterm infants 29-33 weeks gestational age at birth
34 weeks corrected age
off respiratory support \>1.5 lpm

Exclusion

on respiratory support \>1.5 lpm
congenital anomalies

What this trial measures

  • cardiorespiratory eventsDuring 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 hypoxemiaDuring the 24 hour period of randomized blocks of womb sound recordings and ambient noise

    falls in oxygen saturation \<85%

  • mean heart rateDuring the 24 hour period of randomized blocks of womb sound recordings and ambient noise

    mean heart rate

  • bradycardiaDuring the 24 hour period of randomized blocks of womb sound recordings and ambient noise

    heart rate \<80bpm

  • body motionDuring the 24 hour period of randomized blocks of womb sound recordings and ambient noise

    non-cardiac alterations in the oximeter plethysmograph waveform

  • respiratory pausesDuring 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.