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

Primary Purpose

Apnea of Prematurity, Intermittent Hypoxemia, Bradycardia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Womb sound recordings
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Apnea of Prematurity focused on measuring apnea, intermittent hypoxemia, bradycardia, audio recording

Eligibility Criteria

1 Week - 5 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Ambient noise followed by Womb sound

Womb sound recordings followed by ambient noise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

cardiorespiratory events
Apnea (>20 seconds or shorter with intermittent hypoxemia <85% or bradycardia <80bpm)
intermittent hypoxemia
falls in oxygen saturation <85%
mean heart rate
mean heart rate
bradycardia
heart rate <80bpm
body motion
non-cardiac alterations in the oximeter plethysmograph waveform
respiratory pauses
Respiratory pauses of >5sec will be documented to increase the chance of capturing small alterations in respiratory stability.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2022
Last Updated
August 29, 2023
Sponsor
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT05298748
Brief Title
The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants
Official Title
Womb Recordings and Respiratory Control Maturation in Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Prematurity, Intermittent Hypoxemia, Bradycardia
Keywords
apnea, intermittent hypoxemia, bradycardia, audio recording

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single site, single visit study. The order of exposure, two 6 hour periods of ambient noise and two 6 hour periods of sound, will be randomized within each subject for a total of 24hrs of sound exposure.
Masking
Outcomes Assessor
Masking Description
The order of the sound exposure will be randomized within each subject. The outcomes assessor (quantifying cardiorespiratory events) will be blinded as to the order of the 6 hour randomization blocks within the 24 hour study.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ambient noise followed by Womb sound
Arm Type
Other
Arm Description
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.
Arm Title
Womb sound recordings followed by ambient noise
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Womb sound recordings
Intervention Description
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 Information:
Title
cardiorespiratory events
Description
Apnea (>20 seconds or shorter with intermittent hypoxemia <85% or bradycardia <80bpm)
Time Frame
During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Title
intermittent hypoxemia
Description
falls in oxygen saturation <85%
Time Frame
During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Title
mean heart rate
Description
mean heart rate
Time Frame
During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Title
bradycardia
Description
heart rate <80bpm
Time Frame
During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Title
body motion
Description
non-cardiac alterations in the oximeter plethysmograph waveform
Time Frame
During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Title
respiratory pauses
Description
Respiratory pauses of >5sec will be documented to increase the chance of capturing small alterations in respiratory stability.
Time Frame
During the 24 hour period of randomized blocks of womb sound recordings and ambient noise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
5 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Bearer, MD
Phone
216 844-3387
Email
Cynthia.Bearer@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Bearer, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-7061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Associate Chief Scientific Officer
First Name & Middle Initial & Last Name & Degree
Cynthia Bearer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants

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