Womb Recordings and Respiratory Control Maturation in Neonates
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Apnea of Prematurity
- Sponsor
- Case Western Reserve University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- mean heart rate
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
mean heart rate
Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
mean heart rate
respiratory pauses
Time Frame: 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.
cardiorespiratory events
Time Frame: 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
Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
falls in oxygen saturation \<85%
bradycardia
Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
heart rate \<80bpm
body motion
Time Frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
non-cardiac alterations in the oximeter plethysmograph waveform