MedTrace Logo

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

NCT04821011 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2021-09-10

No results posted yet for this study

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.

Conditions

  • Premature Birth

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Hugues PATURAL, MD PhD · CHU SAINT-ETIENNE

Eligibility

Min Age
4 Days
Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2021-06-27
Completion
2021-06-27

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821011 on ClinicalTrials.gov