Womb Sound Recordings for Preterm Infant Respiratory Development

Overseen By Cynthia Bearer, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Congenital anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how listening to womb sounds may aid the development of the brain's breathing centers in preterm infants. Researchers will play recordings of womb sounds and compare them to regular hospital noise to assess any impact on respiratory development. The trial seeks preterm infants born between 29-33 weeks who are 34 weeks old and breathing independently. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance care for future 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.

What prior data suggests that womb sound recordings are safe for preterm infants?

Research has shown that playing recordings of womb sounds can be safe for premature babies. Studies suggest these sounds might aid in breathing, reduce pain, and improve sleep. These recordings are considered low risk and are unlikely to harm the baby's health.

Experts note that sounds can have both positive and negative effects on babies, with the type and volume of sound being crucial. The American Academy of Pediatrics advises maintaining safe noise levels in neonatal intensive care units (NICUs), and these womb sounds meet those guidelines.

In summary, while sound exposure requires careful management, evidence indicates that womb sound recordings are generally well-tolerated and could benefit premature babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using womb sound recordings for preterm infant respiratory development because this approach is non-invasive and uses natural sounds to potentially enhance lung function. Unlike current treatments that often involve medical interventions or devices, this method introduces preterm infants to familiar, soothing womb sounds, which may aid in calming and stabilizing their breathing. By alternating these womb sounds with ambient noise, the trial aims to understand how sound exposure can positively influence respiratory outcomes, offering a gentle and potentially effective way to support these vulnerable infants.

What evidence suggests that womb sound recordings are effective for preterm infant respiratory development?

This trial will compare the effects of womb sound recordings with ambient noise on preterm infants' respiratory development. Research has shown that playing recordings of womb sounds can aid in the development of preterm babies. These sounds mimic the womb environment and may accelerate the maturation of brain areas that control breathing. Studies have found that when premature babies hear these sounds, their breathing stabilizes, and their oxygen levels drop less frequently. This sound exposure is considered a low-risk method to enhance newborns' breathing control. Additionally, these sounds have been linked to improved heart and behavioral stability in infants. ^{6 7 8 9 10}

Who Is on the Research Team?

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?

Group I: Womb sound recordings followed by ambient noise Experimental Treatment 1 Intervention

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.

Group II: Ambient noise followed by Womb sound Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Published Research Related to This Trial

Monitoring infant cries can provide valuable insights into their respiratory health, especially for preterm and low-birth-weight infants who are at risk for respiratory issues.

A new software tool has been developed to analyze the acoustic features of infant cries, allowing for non-invasive and effective tracking of important respiratory parameters in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution cry analysis in preterm newborn infants. Manfredi, C., Bocchi, L., Orlandi, S., et al.[2009]

The study investigates the cry characteristics of preterm newborns, focusing on the relationships between fundamental frequency and vocal tract resonance frequencies, which may indicate central nervous system development.

A new recording system was developed to non-invasively monitor blood oxygenation and audio recordings of cries, revealing potential distress in preterm infants linked to decreased blood oxygen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive distress evaluation in preterm newborn infants. Manfredi, C., Bocchi, L., Orlandi, S., et al.[2020]

The study analyzed how newborns respond to sound stimuli by measuring changes in their breathing patterns, specifically looking at mean cycle time and variability in cycle times.

The findings indicate that the respiratory responses to acoustic stimuli are consistent and can be reliably assessed using both statistical and visual analysis methods, suggesting a robust way to evaluate neonatal responses in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trials with the Auditory Response Cradle. II--The neonatal respiratory response to an auditory stimulus. Bennett, MJ., Lawrence, RJ.[2019]

In a study measuring short duration sounds in a neonatal intensive care unit over 48 hours, 31% of the sounds exceeded 90 dB, indicating potentially harmful noise levels for infants.

The intensity of these sounds varied significantly based on the day, week, location, and time, with a notable 16% increase in sound levels during physician rounds, highlighting the need for improved sound control strategies to protect vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peak noise distribution in the neonatal intensive care nursery. Robertson, A., Cooper-Peel, C., Vos, P.[2004]

The described portable data-acquisition system allows for long-term, noninvasive monitoring of physiological and behavioral variables in preterm infants, which is essential for understanding their sleep-wake state organization.

The system operates continuously for 48 hours, collecting real-time electrophysiological data in the neonatal intensive care unit (NICU) and transferring it for analysis, ensuring minimal disruption to the infants' care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a data-acquisition system for monitoring sleep organization in preterm infants. Drakulic, BS., Garbanati, JA., Gold, MN.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of maternal sound stimulation on preterm infants: A systematic review and meta-analysis. Li, Y., Zhang, J., Yang, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05298748

The Effect of Womb Recordings on Maturation of Respiratory ... 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 ...

2. withpower.com withpower.com/trial/phase-hypoxia-5-2022-943b2

Womb Sound Recordings for Preterm Infant Respiratory ... Research suggests that environments mimicking womb sounds may support the development of preterm infants by providing a familiar sound environment that reflects ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11624134/

The effect of early postnatal auditory stimulation on outcomes ... This review explores the range of postnatal auditory stimuli being investigated in the field of neonatology and their effects on preterm infant outcomes.

4. trial.medpath.com trial.medpath.com/clinical-trial/723f7be40cf5a0fb/effect-womb-recordings-maturation-respiratory-control-preterm-infants

The Effect of Womb Recordings on Maturation of Respiratory ... These sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce maturation of ...

5. pnas.org pnas.org/doi/10.1073/pnas.1507315112

Does exposure of premature infants to repetitive recorded ... Recent studies have demonstrated that exposure of premature infants to maternal sound is associated with more cardiovascular and behavioral stability.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5944959/

A description of externally recorded womb sounds in ... Womb-like sounds may be a powerful tool in aiding cardiorespiratory stability, pain mitigation, and sleep promotion in infants.[11–15] Instead ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0884217515311011

Safe Sound Exposure in the Fetus and Preterm Infant Exposure to sound can have beneficial and harmful effects on the developing fetus and preterm infant. Although recommendations for safe exposure to sound ...

8. clinicaltrial.be clinicaltrial.be/en/details/174780?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

The Effect of Womb Recordings on Maturation of Respirator... These sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce ...

9. uhhospitals.org uhhospitals.org/uh-research/find-clinical-trials-and-studies/clinical-trials-search/womb-recordings-and-respiration-in-preterm-infants-12389

Womb Recordings and Respiration in Preterm Infants The objective of this study is to see if a premature babies exposure to womb-like sounds of preterm infants in the NICU will induce a more mature and stabilized ...

10. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2024.1379249/full

“Every breath you take”: evaluating sound levels and ... According to the American Academy for Pediatrics (AAP), the noise level in NICUs shall not exceed 45 dB during daytime and 35 dB at night. The ...