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

Premature Birth Clinical Trial

— Cardio_Sound  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821011
• Other study ID #: IRBN462021/CHUSTE
• Status: Completed
• Start date: April 23, 2021
• Est. completion date: June 27, 2021

Study information

• Verified date: March 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study will imply 40 preterm and term newborns hospitalized in neonatal intensive care units of the University Hospital of Saint-Etienne (France).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 27, 2021
• Est. primary completion date: June 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Device:
• electronic stethoscope
Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.
• acoustic listening of mother's heartbeats
Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.
• 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 NIPS index of comfort (MDMS® NIPS monitor) will be used.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIPS index	Analyze variations of the activity of the autonomic nervous system (R-R cardiac interval); NIPS index (from 0 to 100) obtained from an MDoloris® monitor.; The base line is measured one hour before	During the acoustic listening
Secondary	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
Secondary	HFnu (normalized high frequency) index.	Measured by analyze of record's of newborn heart rate.	One hour after the acoustic listening
Secondary	Standard deviation of all NN intervals (SDNN)	Measured by analyze of record's of newborn heart rate	During the acoustic listening
Secondary	Standard deviation of all NN intervals (SDNN)	Measured by analyze of record's of newborn heart rate	One hour after the acoustic listening
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total power spectrum (Ptot)	Measured by analyze of record's of newborn heart rate.	During the acoustic listening
Secondary	Total power spectrum (Ptot)	Measured by analyze of record's of newborn heart rate.	One hour after the acoustic listening
Secondary	Low Frequency (LF)	Measured by analyze of record's of newborn heart rate.	During the acoustic listening
Secondary	Low Frequency (LF)	Measured by analyze of record's of newborn heart rate.	One hour the acoustic listening
Secondary	High Frequency (HF)	Measured by analyze of record's of newborn heart rate.	During the acoustic listening
Secondary	High Frequency (HF)	Measured by analyze of record's of newborn heart rate.	One hour after the acoustic listening
Secondary	Very Low Frequency (VLF)	Measured by analyze of record's of newborn heart rate.	During the acoustic listening
Secondary	Very Low Frequency (VLF)	Measured by analyze of record's of newborn heart rate.	One hour after the acoustic listening
Secondary	Ratio Low Frequency (LF) / High Frequency (HF)	Measured by analyze of record's of newborn heart rate.	During the acoustic listening
Secondary	Ratio Low Frequency (LF) / High Frequency (HF)	Measured by analyze of record's of newborn heart rate.	One hour after the acoustic listening
Secondary	Heart rate (bpm)	Measured by analyze of record's of newborn heart rate.	During the acoustic listening
Secondary	Oxygen saturation (%)	Measured by analyze of record's of newborn heart rate.	During the acoustic listening
Secondary	NIPS index	Analyze variations of the activity of the autonomic nervous system (R-R cardiac interval); NIPS index (from 0 to 100) obtained from an MDoloris® monitor.	One hour after the acoustic listening