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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Premature Birth

Treatments: Device: electronic stethoscope; Device: Recording of the newborn's heart rate; Device: acoustic listening of mother's heartbeats

Study type: Observational

Funder types: Other

Identifiers

NCT04821011

IRBN462021/CHUSTE

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 4 to 10 days old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Newborn birth between 28 and 40 Weeks of Gestational Age (wGA)

Description:

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.

Treatment:

Device: acoustic listening of mother's heartbeats

Device: Recording of the newborn's heart rate

Device: electronic stethoscope