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

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Device: electronic stethoscope; Device: acoustic listening of mother's heartbeats; Device: Recording of the newborn's heart rate

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 days to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) will be included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: electronic stethoscope; Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.; Other Names: Littmann® Electronic 3200; Device: acoustic listening of mother's heartbeats; Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.; Device: Recording 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.; Other Names: Philips® IntelliVue MX700 monitor; MDMS® NIPΣ monitor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Actual): June 27, 2021
• Study Completion (Actual): June 27, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Newborn; Premature; Heart rate Variability; Maternal heart beat; Autonomous nervous system
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: IRBN462021/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No