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

Bradycardia Clinical Trial

Official title:

Womb Recordings and Respiratory Control Maturation in Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05298748
• Other study ID #: STUDY20211638
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Case Western Reserve University
• Contact: Cynthia Bearer, MD
• Phone: 216 844-3387
• Email: Cynthia.Bearer[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Week to 5 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Apnea of Prematurity
• Bradycardia
• Hypoxia
• Intermittent Hypoxemia

Intervention

Other:
• Womb 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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

References & Publications (32)

Almadhoob A, Ohlsson A. Sound reduction management in the neonatal intensive care unit for preterm or very low birth weight infants. Cochrane Database Syst Rev. 2015 Jan 30;1:CD010333. doi: 10.1002/14651858.CD010333.pub2. — View Citation

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Coleman RJ, Beharry KD, Brock RS, Abad-Santos P, Abad-Santos M, Modanlou HD. Effects of brief, clustered versus dispersed hypoxic episodes on systemic and ocular growth factors in a rat model of oxygen-induced retinopathy. Pediatr Res. 2008 Jul;64(1):50-5 — View Citation

Corrigan MJ, Keeler JR, Miller HD, Ben Khallouq BA, Fowler SB. Music therapy and retinopathy of prematurity screening: using recorded maternal singing and heartbeat for post exam recovery. J Perinatol. 2020 Dec;40(12):1780-1788. doi: 10.1038/s41372-020-07 — View Citation

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Di Fiore JM, Kaffashi F, Loparo K, Sattar A, Schluchter M, Foglyano R, Martin RJ, Wilson CG. The relationship between patterns of intermittent hypoxia and retinopathy of prematurity in preterm infants. Pediatr Res. 2012 Dec;72(6):606-12. doi: 10.1038/pr.2 — View Citation

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Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15. — View Citation

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Parga JJ, Bhatt RR, Kesavan K, Sim MS, Karp HN, Harper RM, Zeltzer L. A prospective observational cohort study of exposure to womb-like sounds to stabilize breathing and cardiovascular patterns in preterm neonates. J Matern Fetal Neonatal Med. 2018 Sep;31 — View Citation

Parga JJ, Daland R, Kesavan K, Macey PM, Zeltzer L, Harper RM. A description of externally recorded womb sounds in human subjects during gestation. PLoS One. 2018 May 10;13(5):e0197045. doi: 10.1371/journal.pone.0197045. eCollection 2018. — View Citation

Peng YJ, Prabhakar NR. Effect of two paradigms of chronic intermittent hypoxia on carotid body sensory activity. J Appl Physiol (1985). 2004 Mar;96(3):1236-42; discussion 1196. doi: 10.1152/japplphysiol.00820.2003. Epub 2003 Dec 5. — View Citation

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Raffaeli G, Manzoni F, Cortesi V, Cavallaro G, Mosca F, Ghirardello S. Iron Homeostasis Disruption and Oxidative Stress in Preterm Newborns. Nutrients. 2020 May 27;12(6):1554. doi: 10.3390/nu12061554. — View Citation

Raffay TM, Dylag AM, Sattar A, Abu Jawdeh EG, Cao S, Pax BM, Loparo KA, Martin RJ, Di Fiore JM. Neonatal intermittent hypoxemia events are associated with diagnosis of bronchopulmonary dysplasia at 36 weeks postmenstrual age. Pediatr Res. 2019 Feb;85(3):3 — View Citation

Rains ME, Muncie CB, Pang Y, Fan LW, Tien LT, Ojeda NB. Oxidative Stress and Neurodevelopmental Outcomes in Rat Offspring with Intrauterine Growth Restriction Induced by Reduced Uterine Perfusion. Brain Sci. 2021 Jan 8;11(1):78. doi: 10.3390/brainsci11010 — View Citation

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Reeves SR, Mitchell GS, Gozal D. Early postnatal chronic intermittent hypoxia modifies hypoxic respiratory responses and long-term phrenic facilitation in adult rats. Am J Physiol Regul Integr Comp Physiol. 2006 Jun;290(6):R1664-71. doi: 10.1152/ajpregu.0 — View Citation

Smith CV, Satt B, Phelan JP, Paul RH. Intrauterine sound levels: intrapartum assessment with an intrauterine microphone. Am J Perinatol. 1990 Oct;7(4):312-5. doi: 10.1055/s-2007-999511. — View Citation

Smith SW, Ortmann AJ, Clark WW. Noise in the neonatal intensive care unit: a new approach to examining acoustic events. Noise Health. 2018 Jul-Aug;20(95):121-130. doi: 10.4103/nah.NAH_53_17. — View Citation

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiorespiratory events	Apnea (>20 seconds or shorter with intermittent hypoxemia <85% or bradycardia <80bpm)	During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Primary	intermittent hypoxemia	falls in oxygen saturation <85%	During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Primary	mean heart rate	mean heart rate	During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Primary	bradycardia	heart rate <80bpm	During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Primary	body motion	non-cardiac alterations in the oximeter plethysmograph waveform	During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Primary	respiratory pauses	Respiratory pauses of >5sec will be documented to increase the chance of capturing small alterations in respiratory stability.	During the 24 hour period of randomized blocks of womb sound recordings and ambient noise