Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns
NCT ID: NCT04821011
Last Updated: 2021-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2021-04-23
2021-06-27
Brief Summary
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During the uterine life fetus benefits previously of several auditory stimulations by the maternal voice, the mother's heartbeat. After birth the auditory environment is dramatically modified.
Aim of this study is to submit to the newborn an audio recording of his mother's heart beat to analyze the comfort, stress and autonomic response. Heart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity in the sympathetic-parasympathetic balance. This one can be simply assess by a monitor named NIPΣ and can provide a comfort index by quantifying the parasympathetic tone.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newborn birth between 28 and 40 Weeks of Gestational Age (wGA)
Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) will be included. The mother's newborn will be have a record of her heartbeats.
The newborn will be have an acoustic listening of their mother's heartbeat and a record of their own heartbeats.
electronic stethoscope
Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.
acoustic listening of mother's heartbeats
Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.
Recording of the newborn's heart rate
Recording of the newborn's heart rate: one hour before the acoustic listening, during the acoustic listening and one hour after the acoustic listening .
The variations of the autonomic nervous system will be analyzed.
An coupled Heart rate variability recording (ECG signal obtained from a Philips® IntelliVue MX700 monitor) and NIPΣ index of comfort (MDMS® NIPΣ monitor) will be used.
Interventions
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electronic stethoscope
Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.
acoustic listening of mother's heartbeats
Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.
Recording of the newborn's heart rate
Recording of the newborn's heart rate: one hour before the acoustic listening, during the acoustic listening and one hour after the acoustic listening .
The variations of the autonomic nervous system will be analyzed.
An coupled Heart rate variability recording (ECG signal obtained from a Philips® IntelliVue MX700 monitor) and NIPΣ index of comfort (MDMS® NIPΣ monitor) will be used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hospitalized in the neonatal intensive care units of the university hospital of Saint-Etienne (France)
Exclusion Criteria
* Uncontrolled sepsis
* Sedation on going
* Treatment known to modify the sympathetic or parasympathetic activity of the autonomic nervous system
* Congenital disease
* Congenital ear pathology
4 Days
10 Days
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Hugues PATURAL, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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Chu Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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IRBN462021/CHUSTE
Identifier Type: -
Identifier Source: org_study_id
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