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

February 15, 2024 updated by: Case Western Reserve University

Womb Recordings and Respiratory Control Maturation in Neonates

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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. 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.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-7061
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
          • Associate Chief Scientific Officer
        • Principal Investigator:
          • Cynthia Bearer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
falls in oxygen saturation <85%
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
mean heart rate
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
heart rate <80bpm
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
non-cardiac alterations in the oximeter plethysmograph waveform
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
Respiratory pauses of >5sec will be documented to increase the chance of capturing small alterations in respiratory stability.
During the 24 hour period of randomized blocks of womb sound recordings and ambient noise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Investigators

  • Principal Investigator: Cynthia Bearer, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20211638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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