The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants

Case Western Reserve University

Status: Enrolling

Conditions: Bradycardia; Apnea of Prematurity; Intermittent Hypoxemia

Treatments: Other: Womb sound recordings

Study type: Interventional

Funder types: Other

Identifiers

NCT05298748

STUDY20211638

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 1 to 5 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Ambient noise followed by Womb sound

Other group

Description:

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.

Treatment:

Other: Womb sound recordings

Womb sound recordings followed by ambient noise

Other group

Description:

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.

Treatment:

Other: Womb sound recordings