The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Womb sound recordings.
- Who it may be relevant to
- Registry conditions: Apnea of Prematurity, Intermittent Hypoxemia, Bradycardia. Basic parameters: 1 Week — 5 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Womb Recordings and Respiratory Control Maturation in Neonates
Overview
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.
Interventions
- 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.
Primary outcome measures
- cardiorespiratory events [Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise]
- intermittent hypoxemia [Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise]
- mean heart rate [Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise]
- bradycardia [Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise]
- body motion [Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise]
- respiratory pauses [Time frame: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University Hospitals Cleveland Medical Center — Cleveland
Publications
- Noise: a hazard for the fetus and newborn. American Academy of Pediatrics. Committee on Environmental Health. Pediatrics. 1997 Oct;100(4):724-7. No abstract available. PMID 9836852
- Jobe AH, Bancalari E. An All-Inclusive Perspective on Bronchopulmonary Dysplasia. J Pediatr. 2021 Jul;234:257-259. doi: 10.1016/j.jpeds.2021.03.063. Epub 2021 Apr 1. No abstract available. PMID 33811871
- White RD, Smith JA, Shepley MM; Committee to Establish Recommended Standards for Newborn ICU Design. Recommended standards for newborn ICU design, eighth edition. J Perinatol. 2013 Apr;33 Suppl 1:S2-16. doi: 10.1038/jp.2013.10. PMID 23536026
- 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. PMID 25633155
- Barateiro A, Brites D, Fernandes A. Oligodendrocyte Development and Myelination in Neurodevelopment: Molecular Mechanisms in Health and Disease. Curr Pharm Des. 2016;22(6):656-79. doi: 10.2174/1381612822666151204000636. PMID 26635271
- Benzaquen S, Gagnon R, Hunse C, Foreman J. The intrauterine sound environment of the human fetus during labor. Am J Obstet Gynecol. 1990 Aug;163(2):484-90. doi: 10.1016/0002-9378(90)91180-k. PMID 2386134
- Brockmann PE, Wiechers C, Pantalitschka T, Diebold J, Vagedes J, Poets CF. Under-recognition of alarms in a neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F524-7. doi: 10.1136/archdischild-2012-303369. Epub 2013 May 28. PMID 23716498
- 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. doi: 10.1203/PDR.0b013e31817307ac. PMID 18344903
Identifiers
NCT: NCT05298748 · STUDY20211638