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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.
The study will imply 40 preterm and term newborns hospitalized in neonatal intensive care units of the University Hospital of Saint-Etienne (France).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electronic stethoscope | Device | Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Hugues PATURAL, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Saint-Etienne | France |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| acoustic listening of mother's heartbeats | Device | Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded. |
|
| Recording of the newborn's heart rate | Device | 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. |
|
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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 |
| D000091642 | Urogenital Diseases |