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Completed

NCT Number: NCT04821011

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

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

4 day–10 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electronic stethoscope

Device

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

Other names: Littmann® Electronic 3200

acoustic listening of mother's heartbeats

Device

Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.

Recording of the newborn's heart rate

Device

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

Primary outcomes

  1. NIPΣ index

    Time frame: During the acoustic listening

    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

Secondary outcomes

  1. HFnu (normalized high frequency) index.

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate.

    The base line is measured one hour before

  2. HFnu (normalized high frequency) index.

    Time frame: One hour after the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  3. Standard deviation of all NN intervals (SDNN)

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate

  4. Standard deviation of all NN intervals (SDNN)

    Time frame: One hour after the acoustic listening

    Measured by analyze of record's of newborn heart rate

  5. Proportion of NN50 divided by the total number of NN intervals (pNN50)

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate

  6. Proportion of NN50 divided by the total number of NN intervals (pNN50)

    Time frame: One hour after the acoustic listening

    Measured by analyze of record's of newborn heart rate

  7. Root mean square of the successive differences (RMSSD).of RR interval

    Time frame: One hour after the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  8. Root mean square of the successive differences (RMSSD).of RR interval

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  9. Total power spectrum (Ptot)

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  10. Total power spectrum (Ptot)

    Time frame: One hour after the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  11. Low Frequency (LF)

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  12. Low Frequency (LF)

    Time frame: One hour the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  13. High Frequency (HF)

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  14. High Frequency (HF)

    Time frame: One hour after the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  15. Very Low Frequency (VLF)

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  16. Very Low Frequency (VLF)

    Time frame: One hour after the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  17. Ratio Low Frequency (LF) / High Frequency (HF)

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  18. Ratio Low Frequency (LF) / High Frequency (HF)

    Time frame: One hour after the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  19. Heart rate (bpm)

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  20. Oxygen saturation (%)

    Time frame: During the acoustic listening

    Measured by analyze of record's of newborn heart rate.

  21. NIPΣ index

    Time frame: One hour after the acoustic listening

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: Cardio_Sound

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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