Womb Sound Recordings for Preterm Infant Respiratory Development
Recruiting in Palo Alto (17 mi)
Overseen byCynthia Bearer, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Case Western Reserve University
Disqualifiers: Congenital anomalies, others
No Placebo Group
Trial Summary
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.
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.
12345How 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.
14678Eligibility Criteria
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Womb sound recordings followed by ambient noiseExperimental Treatment1 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 soundExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Hospitals Cleveland Medical CenterCleveland, OH
Loading ...
Who Is Running the Clinical Trial?
Case Western Reserve UniversityLead Sponsor
References
A description of externally recorded womb sounds in human subjects during gestation. [2018]Reducing environmental noise benefits premature infants in neonatal intensive care units (NICU), but excessive reduction may lead to sensory deprivation, compromising development. Instead of minimal noise levels, environments that mimic intrauterine soundscapes may facilitate infant development by providing a sound environment reflecting fetal life. This soundscape may support autonomic and emotional development in preterm infants. We aimed to assess the efficacy and feasibility of external non-invasive recordings in pregnant women, endeavoring to capture intra-abdominal or womb sounds during pregnancy with electronic stethoscopes and build a womb sound library to assess sound trends with gestational development. We also compared these sounds to popular commercial womb sounds marketed to new parents.
Acoustic analysis of neonatal breath sounds using digital stethoscope technology. [2020]There is no published literature regarding the use of the digital stethoscope (DS) and computerized breath sound analysis in neonates, despite neonates experiencing a high burden of respiratory disease. We aimed to determine if the DS could be used to study breath sounds of term and preterm neonates without respiratory disease, and detect a difference in acoustic characteristics between them.
Effects of maternal sound stimulation on preterm infants: A systematic review and meta-analysis. [2023]To evaluate the effects of maternal sound stimulation on preterm infants.
Non-invasive distress evaluation in preterm newborn infants. [2020]With the increased survival of very preterm infants, there is a growing concern for their developmental outcomes. Infant cry characteristics reflect the development and possibly the integrity of the central nervous system. In this paper, relationships between fundamental frequency (F(0)) and vocal tract resonance frequencies (F(1)-F(3)) are investigated for a set of preterm newborns, by means of a multi-purpose voice analysis tool (BioVoice), characterised by high-resolution and tracking capabilities. Also, first results about possible distress occurring during cry in preterm newborn infants, as related to the decrease of central blood oxygenation, are presented. To this aim, a recording system (Newborn Recorder) has been developed, that allows synchronised, non-invasive monitoring of blood oxygenation and audio recordings of newborn infant's cry. The method has been applied to preterm newborns at the Intensive Care Unit, A.Meyer Children Hospital, Firenze, Italy.
Design of a data-acquisition system for monitoring sleep organization in preterm infants. [2016]A portable data-acquisition system suitable for long-term noninvasive monitoring of physiologic and behavioral variables in preterm infants is described. The system includes two video cameras, a video screen-splitter and amplifier, a time-lapse video recorder, a microphone, a force-responsive transducer, an analog signal conditioner, and two microcomputers. One microcomputer, located in the neonatal intensive care unit (NICU) acquires electrophysiologic signals and preprocesses data in real time, during a continuous 48-hour session. After each session, the data file is transferred by telephone line to the other microcomputer, located in a laboratory, for editing, reduction, display, and final analysis. This arrangement enables noninvasive and nonintrusive monitoring, which is crucial for long-term recording of sleep-wake state organization of preterm infants.
High-resolution cry analysis in preterm newborn infants. [2009]Infant monitoring is a common procedure in clinical practice in neonatal critical care units. A number of vital functions are monitored, such as heart beat, breathing, blood flow, etc. Specifically, preterm and/or low-birth-weight infants often present respiratory problems that require monitoring. These may range from insufficient ventilation to apnoea. One of the most common events that may affect the respiratory flow is crying, a physiological action made by the infant to communicate and draw attention, but, for a preterm infant, this action requires great effort, which may cause distress and even may have an adverse impact on blood oxygenation. Acoustic analysis of newborn infant cry is thus of importance, since it is related to other basic neuro-physiological parameters. Being easy to perform, cheap and completely non-invasive, it can be successfully applied in many circumstances. The newborn infant cry is characterised by very high fundamental frequency (F(0)) and resonance frequency (RFs) values, with abrupt changes and voiced/unvoiced features of very short duration in a single utterance. To deal with such signals, a new user-friendly software tool has been developed, that allows robust tracking of main acoustic parameters on very short and time-varying signal frames. The software developed provides the user with a high-resolution picture of the cry signal characteristics.
Trials with the Auditory Response Cradle. II--The neonatal respiratory response to an auditory stimulus. [2019]The respiratory response of the neonate to an acoustic stimulus is analysed. It is shown that a response may be indicated by (i) a change in the mean cycle time, (ii) a change in the variability of cycle times, (iii) short or long cycles in the sound-on-period following a regular sequence prior to the stimulus. Responses were found to be independent of the pre-stimulus mean cycle time and variability subject to certain restriction. Decision rules are formulated and applied to the Auditory Response Cradle test results. Good agreement is found between statistical and visual methods of trace analysis.
Peak noise distribution in the neonatal intensive care nursery. [2004]To measure short duration sounds (L(PEAK)) in the neonatal intensive care unit and describe their intensity, incidence, and periodicity in relationship to activities within the unit.