The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorCase Western Reserve University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
preterm infants 29-33 weeks gestational age at birth
34 weeks corrected age
off respiratory support >1.5 lpm
Disqualifiers
on respiratory support >1.5 lpm
congenital anomalies
Trial design
Design model
Single group
Treatments tested in this trial
Womb sound recordings
Other interventionWomb 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Ambient noise followed by Womb soundOther 1 intervention
Group B: Womb sound recordings followed by ambient noiseOther 1 intervention
Trial outcomes
Primary outcomes
1
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 noise2
intermittent hypoxemia
falls in oxygen saturation \<85%
Time frame
During the 24 hour period of randomized blocks of womb sound recordings and ambient noise3
mean heart rate
mean heart rate
Time frame
During the 24 hour period of randomized blocks of womb sound recordings and ambient noise4
bradycardia
heart rate \<80bpm
Time frame
During the 24 hour period of randomized blocks of womb sound recordings and ambient noiseSponsors and contacts
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Source ClinicalTrials.gov