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NCT Number: NCT05298748

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

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.

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Key information

Conditions

Apnea of Prematurity Apnea Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Intermittent Hypoxemia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 week–5 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-7061, United States

Location status: Recruiting

Location contact

Associate Chief Scientific Officer

CONTACT

Cynthia Bearer, MD

PRINCIPAL_INVESTIGATOR

About this study

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. We hypothesize that exposure to appropriately designed womb-like sounds in the Neonatal Intensive Care Unit (NICU) will induce a more mature and stabilized cardiorespiratory pattern manifesting as a decrease in apnea, bradycardia, intermittent hypoxemia and mean heart rate.

This proposal lays the foundation for further development of actual womb and maternal voice recordings containing components that closely mimic the womb environment during 33-34 weeks of gestation, a proposed therapeutic window of brain development. These sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce maturation of neuronal respiratory networks during this critical stage of development.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Womb sound recordings

Other

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 outcomes

  1. 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)

  2. intermittent hypoxemia

    Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise

    falls in oxygen saturation <85%

  3. mean heart rate

    Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise

    mean heart rate

  4. bradycardia

    Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise

    heart rate <80bpm

  5. 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

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Bearer, MD

CONTACT

[email protected]

216 844-3387

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

Womb Recordings and Respiratory Control Maturation in Neonates

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2022
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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