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

NCT04821011 | Completed

• 1 other identifier: IRBN462021/CHUSTE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Premature; Maternal heart beat; Newborn; Heart rate Variability; Autonomous nervous system

Outcome Measures

Primary Outcomes (1)

• NIPΣ index

  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

  During the acoustic listening

Secondary Outcomes (21)

• HFnu (normalized high frequency) index.

  During the acoustic listening

• HFnu (normalized high frequency) index.

  One hour after the acoustic listening

• Standard deviation of all NN intervals (SDNN)

  During the acoustic listening

• Standard deviation of all NN intervals (SDNN)

  One hour after the acoustic listening

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

  During the acoustic listening

Study Arms (1)

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

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.

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

Interventions

electronic stethoscope DEVICE

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

Also known as: Littmann® Electronic 3200

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

acoustic listening of mother's heartbeats DEVICE

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

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

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.

Also known as: Philips® IntelliVue MX700 monitor; MDMS® NIPΣ monitor

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

Eligibility Criteria

• Age: 4 Days - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) will be included.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Hugues PATURAL, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: April 23, 2021
• Primary Completion: June 27, 2021
• Study Completion: June 27, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)