Clinical trial NCT05298748: The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants
Official title: Womb Recordings and Respiratory Control Maturation in Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apnea of Prematurity
Intermittent Hypoxemia
Bradycardia
Keywords: apnea, intermittent hypoxemia, bradycardia, audio recording
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: cardiorespiratory events
timeFrame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
measure: intermittent hypoxemia
timeFrame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
measure: mean heart rate
timeFrame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
measure: bradycardia
timeFrame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
measure: body motion
timeFrame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
measure: respiratory pauses
timeFrame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Cynthia Bearer, MD
role: PRINCIPAL_INVESTIGATOR
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