34 Participants Needed

Womb Sound Recordings for Preterm Infant Respiratory Development

CB
Overseen ByCynthia Bearer, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Case Western Reserve University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

How does the Womb Sound Recordings treatment differ from other treatments for preterm infant respiratory development?

Womb Sound Recordings is unique because it uses recordings of sounds from the womb to create an environment that mimics the natural soundscape experienced by a fetus. This approach aims to support the development of preterm infants by providing familiar auditory stimuli, unlike other treatments that may focus on reducing noise or using medical interventions.12345

What data supports the effectiveness of the treatment Womb Sound Recordings for preterm infant respiratory development?

Research suggests that environments mimicking womb sounds may support the development of preterm infants by providing a familiar sound environment that reflects fetal life, potentially aiding in their autonomic and emotional development.34678

Who Is on the Research Team?

CB

Cynthia Bearer, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for preterm infants born between 29-33 weeks of gestational age, who are now at a corrected age of 34 weeks and not on high-level respiratory support. Infants with congenital anomalies or those needing more intensive respiratory support are excluded.

Inclusion Criteria

My baby was born between 29 and 33 weeks of pregnancy.
I am at least 34 weeks in corrected age.
I don't need extra oxygen of more than 1.5 liters per minute.

Exclusion Criteria

I was born with a physical abnormality.
I need more than 1.5 liters per minute of oxygen support.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Preterm infants are exposed to alternating 6-hour periods of womb sounds and ambient noise over a 24-hour period

1 day
1 visit (in-person)

Follow-up

Participants are monitored for cardiorespiratory events, intermittent hypoxemia, mean heart rate, bradycardia, body motion, and respiratory pauses

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Womb Sound Recordings
Trial Overview The study is testing the effects of playing womb sound recordings to these preterm infants to see if it helps mature their brain's breathing control areas.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Womb sound recordings followed by ambient noiseExperimental Treatment1 Intervention
Group II: Ambient noise followed by Womb soundExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+

Published Research Related to This Trial

Recording high-fidelity intra-abdominal sounds from 50 pregnant women revealed that these sounds vary with gestational age and are dominated by low-frequency noises, which differ significantly from popular commercial womb sounds.
These unique womb sounds, characterized by bowel sounds and lower frequencies, may provide a beneficial sound environment for preterm infants in NICUs, potentially supporting their development without causing sensory deprivation.
A description of externally recorded womb sounds in human subjects during gestation.Parga, JJ., Daland, R., Kesavan, K., et al.[2018]
The study successfully used a digital stethoscope to analyze breath sounds in 26 term and 26 preterm neonates, demonstrating that this technology can effectively capture and differentiate acoustic characteristics in neonates without respiratory disease.
Significant differences in breath sound frequencies were found between term and preterm infants, indicating that digital stethoscope technology could be a valuable tool for further research into neonatal respiratory health.
Acoustic analysis of neonatal breath sounds using digital stethoscope technology.Zhou, L., Marzbanrad, F., Ramanathan, A., et al.[2020]
Maternal sound stimulation significantly reduces pain and increases comfort levels in preterm infants during painful procedures, based on a systematic review of 26 studies.
This intervention also improves physiological stability in preterm infants by lowering heart rates and increasing oxygen saturation compared to routine care, making it a highly recommended practice in clinical settings.
Effects of maternal sound stimulation on preterm infants: A systematic review and meta-analysis.Li, Y., Zhang, J., Yang, C., et al.[2023]

Citations

A description of externally recorded womb sounds in human subjects during gestation. [2018]
Acoustic analysis of neonatal breath sounds using digital stethoscope technology. [2020]
Effects of maternal sound stimulation on preterm infants: A systematic review and meta-analysis. [2023]
Non-invasive distress evaluation in preterm newborn infants. [2020]
Design of a data-acquisition system for monitoring sleep organization in preterm infants. [2016]
High-resolution cry analysis in preterm newborn infants. [2009]
Trials with the Auditory Response Cradle. II--The neonatal respiratory response to an auditory stimulus. [2019]
Peak noise distribution in the neonatal intensive care nursery. [2004]
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