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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT05298748
Status
Recruiting
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Conditions

  • Apnea of Prematurity
  • Bradycardia
  • Intermittent Hypoxemia

Eligibility Criteria

Sex
ALL
Age
1 Week - 5 Weeks
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 16, 2022
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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.

Primary Outcome Measure

cardiorespiratory events [ Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106-7061
Associate Chief Scientific Officer
Cynthia Bearer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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