An interventional study of Womb sound recordings in Apnea of Prematurity, Intermittent Hypoxemia and Bradycardia, sponsored by Case Western Reserve University. Recruiting at 1 site in United States. Open to participants aged 1 Week to 5 Weeks. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Prevention
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.
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. We hypothesize that exposure to appropriately designed womb-like sounds in the Neonatal Intensive Care Unit (NICU) will induce a more mature and stabilized cardiorespiratory pattern manifesting as a decrease in apnea, bradycardia, intermittent hypoxemia and mean heart rate.
This proposal lays the foundation for further development of actual womb and maternal voice recordings containing components that closely mimic the womb environment during 33-34 weeks of gestation, a proposed therapeutic window of brain development. These sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce maturation of neuronal respiratory networks during this critical stage of development.
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
This study's planned enrollment of 34 is below the median of 60 across 195 interventional studies indexed under Apnea.
Browse Apnea studies →Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Exclusion Criteria:
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.
Other: Womb sound recordings
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.
Other: Womb sound recordings
Womb sounds will be chosen from commercially available (Amazon) womb recordings using a recording that most closely resembles the womb including maternal heart rate, fetal heartbeat, respiratory sounds, bowel "popping" sounds and frequency spectra as described by Parga, Daland 2018 et al.
cardiorespiratory events
Apnea (\>20 seconds or shorter with intermittent hypoxemia \<85% or bradycardia \<80bpm)
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
intermittent hypoxemia
falls in oxygen saturation \<85%
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
mean heart rate
mean heart rate
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
bradycardia
heart rate \<80bpm
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
body motion
non-cardiac alterations in the oximeter plethysmograph waveform
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
respiratory pauses
Respiratory pauses of \>5sec will be documented to increase the chance of capturing small alterations in respiratory stability.
Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Plan to share: No
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