NCT04821011

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 4 Days – 10 Days
• Healthy volunteers: Not accepted

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).

Conditions

• Premature Birth

Interventions

Type	Name	Description
DEVICE	electronic stethoscope	Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.
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.

Timeline

• Start date: 2021-04-23
• Primary completion: 2021-06-27
• Completion: 2021-06-27
• First posted: 2021-03-29
• Last updated: 2021-09-10

Locations

1 site across 1 country: France