Apnea of Prematurity, Bradycardia, Intermittent Hypoxemia
Conditions
Keywords
apnea, intermittent hypoxemia, bradycardia, audio recording
Brief summary
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.
Detailed description
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.
Interventions
OTHERWomb 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.
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The order of the sound exposure will be randomized within each subject. The outcomes assessor (quantifying cardiorespiratory events) will be blinded as to the order of the 6 hour randomization blocks within the 24 hour study.
Intervention model description
This is a single site, single visit study. The order of exposure, two 6 hour periods of ambient noise and two 6 hour periods of sound, will be randomized within each subject for a total of 24hrs of sound exposure.
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 5 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiorespiratory events | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | Apnea (\>20 seconds or shorter with intermittent hypoxemia \<85% or bradycardia \<80bpm) |
| intermittent hypoxemia | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | falls in oxygen saturation \<85% |
| mean heart rate | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | mean heart rate |
| bradycardia | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | heart rate \<80bpm |
| body motion | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | non-cardiac alterations in the oximeter plethysmograph waveform |
| respiratory pauses | During the 24 hour period of randomized blocks of womb sound recordings and ambient noise | Respiratory pauses of \>5sec will be documented to increase the chance of capturing small alterations in respiratory stability. |
Countries
United States
Contacts
Primary ContactCynthia Bearer, MD
Outcome results
None listed