Recruiting

Womb Recordings

Sponsor:

Case Western Reserve University

Code:

NCT05298748

Conditions

Apnea of Prematurity

Intermittent Hypoxemia

Bradycardia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Womb sound recordings

Study Details

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.

Conditions

Apnea of Prematurity

Intermittent Hypoxemia

Bradycardia

Study ID

NCT05298748

Start date

Sep 16, 2022

Status verified date

Dec, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Ambient noise followed by Womb sound

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.

other: Womb sound recordings followed by ambient noise

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.

Interventions

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 measure

  • cardiorespiratory events [ Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise ]
  • intermittent hypoxemia [ Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise ]
  • mean heart rate [ Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise ]
  • bradycardia [ Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise ]
  • body motion [ Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise ]
  • respiratory pauses [ Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise ]

Central Contacts and Locations

Central contacts

Cynthia Bearer, MD

216 844-3387Cynthia.Bearer@UHhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106-7061

Principal Investigator:

Cynthia Bearer, MD

More Information

Sponsor

Case Western Reserve University

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

  • apnea, intermittent hypoxemia, bradycardia, audio recording

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2025-12-05.