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

NCT05298748 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-12-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Cynthia Bearer, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Week
Max Age
5 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05298748 on ClinicalTrials.gov