Premature Birth
Conditions
Keywords
Premature, Maternal heart beat, Newborn, Heart rate Variability, Autonomous nervous system
Brief summary
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
The study will imply 40 preterm and term newborns hospitalized in neonatal intensive care units of the University Hospital of Saint-Etienne (France).
Interventions
DEVICEelectronic stethoscope
Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.
DEVICEacoustic listening of mother's heartbeats
Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.
DEVICERecording 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.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Days to 10 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIPΣ index | During the acoustic listening | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio Low Frequency (LF) / High Frequency (HF) | During the acoustic listening | Measured by analyze of record's of newborn heart rate. |
| Very Low Frequency (VLF) | During the acoustic listening | Measured by analyze of record's of newborn heart rate. |
| HFnu (normalized high frequency) index. | During the acoustic listening | Measured by analyze of record's of newborn heart rate. The base line is measured one hour before |
| Standard deviation of all NN intervals (SDNN) | During the acoustic listening | Measured by analyze of record's of newborn heart rate |
| Proportion of NN50 divided by the total number of NN intervals (pNN50) | During the acoustic listening | Measured by analyze of record's of newborn heart rate |
| Heart rate (bpm) | During the acoustic listening | Measured by analyze of record's of newborn heart rate. |
| Total power spectrum (Ptot) | During the acoustic listening | Measured by analyze of record's of newborn heart rate. |
| Low Frequency (LF) | During the acoustic listening | Measured by analyze of record's of newborn heart rate. |
| High Frequency (HF) | During the acoustic listening | Measured by analyze of record's of newborn heart rate. |
| Oxygen saturation (%) | During the acoustic listening | Measured by analyze of record's of newborn heart rate. |
| NIPΣ index | One hour after the acoustic listening | 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. |
| Root mean square of the successive differences (RMSSD).of RR interval | One hour after the acoustic listening | Measured by analyze of record's of newborn heart rate. |
Countries
France
Outcome results
None listed