Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns

Study Overview
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Brief Summary
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Prematurity birth lead to an early breaking link with the in utero environment. A special attention is brought in the neonatal intensive care units to reduce noise and lighting surrounding aiming to protect the newborn. 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.

Detailed Description
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The study will imply 40 preterm and term newborns hospitalized in neonatal intensive care units of the University Hospital of Saint-Etienne (France).

Official Title
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Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns

Conditions
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Premature Birth

Intervention / Treatment
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* Device: electronic stethoscope
* Device: acoustic listening of mother's heartbeats
* Device: Recording of the newborn's heart rate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates between 28 and 40 Weeks of Gestational Age (wGA) Hospitalized in the neonatal intensive care units of the university hospital of Saint-Etienne (France) Exclusion Criteria: Respiratory or hemodynamic instability Uncontrolled sepsis Sedation on going Treatment known to modify the sympathetic or parasympathetic activity of the autonomic nervous system Congenital disease Congenital ear pathology

Ages Eligible for Study
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Minimum Age: 4 Days
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborn birth between 28 and 40 Weeks of Gestational Age (wGA)<br>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. | Device: electronic stethoscope<br>* Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.<br>* Other names: Littmann® Electronic 3200;Device: acoustic listening of mother's heartbeats<br>* Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.<br>Device: Recording of the newborn's heart rate<br>* 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.<br>* Other names: Philips® IntelliVue MX700 monitor; MDMS® NIPΣ monitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIPΣ index | Analyze variations of the activity of the autonomic nervous system (R-R cardiac interval) NIPΣ index (from 0 to 100) obtained from an MDoloris® monitor. The base line is measured one hour before | During the acoustic listening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HFnu (normalized high frequency) index. | Measured by analyze of record's of newborn heart rate. The base line is measured one hour before | During the acoustic listening | 
| HFnu (normalized high frequency) index. | Measured by analyze of record's of newborn heart rate. | One hour after the acoustic listening | 
| Standard deviation of all NN intervals (SDNN) | Measured by analyze of record's of newborn heart rate | During the acoustic listening | 
| Standard deviation of all NN intervals (SDNN) | Measured by analyze of record's of newborn heart rate | One hour after the acoustic listening | 
| Proportion of NN50 divided by the total number of NN intervals (pNN50) | Measured by analyze of record's of newborn heart rate | During the acoustic listening | 
| Proportion of NN50 divided by the total number of NN intervals (pNN50) | Measured by analyze of record's of newborn heart rate | One hour after the acoustic listening | 
| Root mean square of the successive differences (RMSSD).of RR interval | Measured by analyze of record's of newborn heart rate. | One hour after the acoustic listening | 
| Root mean square of the successive differences (RMSSD).of RR interval | Measured by analyze of record's of newborn heart rate. | During the acoustic listening | 
| Total power spectrum (Ptot) | Measured by analyze of record's of newborn heart rate. | During the acoustic listening | 
| Total power spectrum (Ptot) | Measured by analyze of record's of newborn heart rate. | One hour after the acoustic listening | 
| Low Frequency (LF) | Measured by analyze of record's of newborn heart rate. | During the acoustic listening | 
| Low Frequency (LF) | Measured by analyze of record's of newborn heart rate. | One hour the acoustic listening | 
| High Frequency (HF) | Measured by analyze of record's of newborn heart rate. | During the acoustic listening | 
| High Frequency (HF) | Measured by analyze of record's of newborn heart rate. | One hour after the acoustic listening | 
| Very Low Frequency (VLF) | Measured by analyze of record's of newborn heart rate. | During the acoustic listening | 
| Very Low Frequency (VLF) | Measured by analyze of record's of newborn heart rate. | One hour after the acoustic listening | 
| Ratio Low Frequency (LF) / High Frequency (HF) | Measured by analyze of record's of newborn heart rate. | During the acoustic listening | 
| Ratio Low Frequency (LF) / High Frequency (HF) | Measured by analyze of record's of newborn heart rate. | One hour after the acoustic listening | 
| Heart rate (bpm) | Measured by analyze of record's of newborn heart rate. | During the acoustic listening | 
| Oxygen saturation (%) | Measured by analyze of record's of newborn heart rate. | During the acoustic listening | 
| NIPΣ index | Analyze variations of the activity of the autonomic nervous system (R-R cardiac interval) NIPΣ index (from 0 to 100) obtained from an MDoloris® monitor. | One hour after the acoustic listening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature, Maternal heart beat, Newborn, Heart rate Variability, Autonomous nervous system