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

Completed

• Conditions: Premature Birth
• Interventions: Device: electronic stethoscope; Device: acoustic listening of mother's heartbeats; Device: Recording of the newborn's heart rate

• Registration Number: NCT04821011
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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).

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Study Start: 2021-04-23
• Primary Completion: 2021-06-27
• Study Completion: 2021-06-27
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newborn birth between 28 and 40 Weeks of Gestational Age (wGA)	electronic stethoscope	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.
Newborn birth between 28 and 40 Weeks of Gestational Age (wGA)	acoustic listening of mother's heartbeats	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.
Newborn birth between 28 and 40 Weeks of Gestational Age (wGA)	Recording of the newborn's heart rate	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Root mean square of the successive differences (RMSSD).of RR interval	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.
Heart rate (bpm)	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)	One hour after the acoustic listening	Measured by analyze of record's of newborn heart rate
Very Low Frequency (VLF)	One hour after the acoustic listening	Measured by analyze of record's of newborn heart rate.
HFnu (normalized high frequency) index.	One hour after the acoustic listening	Measured by analyze of record's of newborn heart rate.
Total power spectrum (Ptot)	One hour after the acoustic listening	Measured by analyze of record's of newborn heart rate.
High Frequency (HF)	One hour after the acoustic listening	Measured by analyze of record's of newborn heart rate.
Ratio Low Frequency (LF) / High Frequency (HF)	One hour after the acoustic listening	Measured by analyze of record's of newborn heart rate.
Standard deviation of all NN intervals (SDNN)	One hour after the acoustic listening	Measured by analyze of record's of newborn heart rate
Low Frequency (LF)	One hour the acoustic listening	Measured by analyze of record's of newborn heart rate.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France