Clinical trial NCT04821011: Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns
Official title: Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: Premature
Maternal heart beat
Newborn
Heart rate Variability
Autonomous nervous system
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) will be included.

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).

Eligibility criteria: 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

Primary outcomes:
measure: NIPΣ index
timeFrame: During the acoustic listening
Secondary outcomes:
measure: HFnu (normalized high frequency) index.
timeFrame: During the acoustic listening
measure: HFnu (normalized high frequency) index.
timeFrame: One hour after the acoustic listening
measure: Standard deviation of all NN intervals (SDNN)
timeFrame: During the acoustic listening
measure: Standard deviation of all NN intervals (SDNN)
timeFrame: One hour after the acoustic listening
measure: Proportion of NN50 divided by the total number of NN intervals (pNN50)
timeFrame: During the acoustic listening
measure: Proportion of NN50 divided by the total number of NN intervals (pNN50)
timeFrame: One hour after the acoustic listening
measure: Root mean square of the successive differences (RMSSD).of RR interval
timeFrame: One hour after the acoustic listening
measure: Root mean square of the successive differences (RMSSD).of RR interval
timeFrame: During the acoustic listening
measure: Total power spectrum (Ptot)
timeFrame: During the acoustic listening
measure: Total power spectrum (Ptot)
timeFrame: One hour after the acoustic listening
measure: Low Frequency (LF)
timeFrame: During the acoustic listening
measure: Low Frequency (LF)
timeFrame: One hour the acoustic listening
measure: High Frequency (HF)
timeFrame: During the acoustic listening
measure: High Frequency (HF)
timeFrame: One hour after the acoustic listening
measure: Very Low Frequency (VLF)
timeFrame: During the acoustic listening
measure: Very Low Frequency (VLF)
timeFrame: One hour after the acoustic listening
measure: Ratio Low Frequency (LF) / High Frequency (HF)
timeFrame: During the acoustic listening
measure: Ratio Low Frequency (LF) / High Frequency (HF)
timeFrame: One hour after the acoustic listening
measure: Heart rate (bpm)
timeFrame: During the acoustic listening
measure: Oxygen saturation (%)
timeFrame: During the acoustic listening
measure: NIPΣ index
timeFrame: One hour after the acoustic listening
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hugues PATURAL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: