Using womb sounds to help preterm infants breathe better
Womb Recordings and Respiratory Control Maturation in Neonates
This study tests if playing womb sounds can help preterm infants breathe better by supporting their brain development during a crucial time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 1 Week to 5 Weeks |
| Sex | All |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05298748 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the effects of womb-like sound exposure on the respiratory control development in preterm infants. By providing audio recordings that mimic the womb environment, researchers hope to enhance neuronal maturation in the brain regions responsible for respiratory control. The study will monitor changes in cardiorespiratory patterns, specifically looking for reductions in apnea, bradycardia, and intermittent hypoxemia. This approach is designed to offer a low-risk intervention during a critical period of brain development for these vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born between 29 to 33 weeks of gestational age who are at least 34 weeks corrected age and off respiratory support.
Not a fit: Patients who are on respiratory support greater than 1.5 liters per minute or have congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve respiratory stability and overall health outcomes for preterm infants.
How similar studies have performed: While the specific approach of using womb recordings is novel, similar studies exploring sound exposure in neonatal care have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Cynthia Bearer, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Cynthia Bearer, MD
- Email: Cynthia.Bearer@UHhospitals.org
- Phone: 216 844-3387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.