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Search / Trial NCT05298748

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

Launched by CASE WESTERN RESERVE UNIVERSITY · Mar 16, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Apnea, Intermittent Hypoxemia, Bradycardia, Audio Recording

ClinConnect Summary

This clinical trial is studying how sounds from the womb can help the brains of preterm infants develop better control over their breathing. Preterm infants often face challenges such as pauses in breathing (called apnea), low oxygen levels (intermittent hypoxemia), and slow heart rates (bradycardia). The researchers want to see if exposing these infants to sounds they heard while in the womb can improve the areas of their brains responsible for breathing control.

To participate in this trial, infants must be born preterm, specifically between 29 and 33 weeks of gestation, and be at least 34 weeks of corrected age. They also need to be off respiratory support that provides more than 1.5 liters of oxygen per minute. Those who are still on high levels of respiratory support or have certain congenital anomalies are not eligible. If your infant qualifies, they will be part of a study that explores the effects of early sound exposure on their development, which could have positive implications for their health and well-being.

Gender

ALL

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

About Case Western Reserve University

Case Western Reserve University (CWRU) is a leading research institution located in Cleveland, Ohio, renowned for its commitment to advancing knowledge and improving health outcomes through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, CWRU integrates expertise from various fields, including medicine, engineering, and social sciences, to address complex health challenges. The university's clinical trial initiatives are designed to foster the development of novel therapies and interventions, ensuring rigorous scientific methodologies and ethical standards are upheld. CWRU is dedicated to translating research findings into tangible benefits for patients and communities, contributing significantly to the advancement of healthcare practices and policies.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Cynthia Bearer, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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