Premature BirthCardio_SoundNCT04821011
Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 days
- Conditions the study is for
- Premature Birth
- What is being tested?
- electronic stethoscope, acoustic listening of mother's heartbeats and Recording of the newborn's heart rate
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2021to 27 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) will be included.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- electronic stethoscope, acoustic listening of mother's heartbeats, Recording of the newborn's heart rate
- Keywords
- Premature, Maternal heart beat, Newborn, Heart rate Variability, Autonomous nervous system
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic stethoscopeDevice
Also called Littmann® Electronic 3200
Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.
acoustic listening of mother's heartbeatsDevice
Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.
Recording of the newborn's heart rateDevice
Also called Philips® IntelliVue MX700 monitor; MDMS® NIPΣ monitor
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: electronic stethoscope; Device: acoustic listening of mother's heartbeats; Device: Recording of the newborn's heart rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the acoustic listening
Secondary outcomes (21)
HFnu (normalized high frequency) index.
Measured by analyze of record's of newborn heart rate.
The base line is measured one hour before
Measured: During the acoustic listening
HFnu (normalized high frequency) index.
Measured by analyze of record's of newborn heart rate.
Measured: One hour after the acoustic listening
Standard deviation of all NN intervals (SDNN)
Measured by analyze of record's of newborn heart rate
Measured: During the acoustic listening
Standard deviation of all NN intervals (SDNN)
Measured by analyze of record's of newborn heart rate
Measured: One hour after the acoustic listening
Proportion of NN50 divided by the total number of NN intervals (pNN50)
Measured by analyze of record's of newborn heart rate
Measured: During the acoustic listening
Proportion of NN50 divided by the total number of NN intervals (pNN50)
Measured by analyze of record's of newborn heart rate
Measured: One hour after the acoustic listening
Root mean square of the successive differences (RMSSD).of RR interval
Measured by analyze of record's of newborn heart rate.
Measured: One hour after the acoustic listening
Root mean square of the successive differences (RMSSD).of RR interval
Measured by analyze of record's of newborn heart rate.
Measured: During the acoustic listening
Total power spectrum (Ptot)
Measured by analyze of record's of newborn heart rate.
Measured: During the acoustic listening
Total power spectrum (Ptot)
Measured by analyze of record's of newborn heart rate.
Measured: One hour after the acoustic listening
Low Frequency (LF)
Measured by analyze of record's of newborn heart rate.
Measured: During the acoustic listening
Low Frequency (LF)
Measured by analyze of record's of newborn heart rate.
Measured: One hour the acoustic listening
High Frequency (HF)
Measured by analyze of record's of newborn heart rate.
Measured: During the acoustic listening
High Frequency (HF)
Measured by analyze of record's of newborn heart rate.
Measured: One hour after the acoustic listening
Very Low Frequency (VLF)
Measured by analyze of record's of newborn heart rate.
Measured: During the acoustic listening
Very Low Frequency (VLF)
Measured by analyze of record's of newborn heart rate.
Measured: One hour after the acoustic listening
Ratio Low Frequency (LF) / High Frequency (HF)
Measured by analyze of record's of newborn heart rate.
Measured: During the acoustic listening
Ratio Low Frequency (LF) / High Frequency (HF)
Measured by analyze of record's of newborn heart rate.
Measured: One hour after the acoustic listening
Heart rate (bpm)
Measured by analyze of record's of newborn heart rate.
Measured: During the acoustic listening
Oxygen saturation (%)
Measured by analyze of record's of newborn heart rate.
Measured: During the acoustic listening
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.
Measured: One hour after the acoustic listening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start23 Apr 2021
- Primary completion27 Jun 2021
- Study completion27 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821011
- Sponsor's protocol ID
- IRBN462021/CHUSTE
- Acronym
- Cardio_Sound
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns
- ClinicalTrials.gov ID
- NCT04821011
- Acronym / sponsor ID
- Cardio_Sound / IRBN462021/CHUSTE
- Conditions
- Premature Birth
- Keywords
- Premature, Maternal heart beat, Newborn, Heart rate Variability, Autonomous nervous system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 27 Jun 2021 (actual)
- Study completion
- 27 Jun 2021 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) | – | Device: electronic stethoscope, Device: acoustic listening of mother's heartbeats, Device: Recording of the newborn's heart rateNewborn 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. |
Who may qualify
- Ages
- 4 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) will be included.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic stethoscopeAlso: Littmann® Electronic 3200Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes. | Device | Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) |
| acoustic listening of mother's heartbeatsEach newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded. | Device | Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) |
| Recording of the newborn's heart rateAlso: Philips® IntelliVue MX700 monitor; MDMS® NIPΣ monitorRecording 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. | Device | Newborn birth between 28 and 40 Weeks of Gestational Age (wGA) |
Primary outcome
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
21 secondary outcomes
HFnu (normalized high frequency) index.
Time frame: During the acoustic listening
HFnu (normalized high frequency) index.
Time frame: One hour after the acoustic listening
Standard deviation of all NN intervals (SDNN)
Time frame: During the acoustic listening
Standard deviation of all NN intervals (SDNN)
Time frame: One hour after the acoustic listening
Proportion of NN50 divided by the total number of NN intervals (pNN50)
Time frame: During the acoustic listening
Proportion of NN50 divided by the total number of NN intervals (pNN50)
Time frame: One hour after the acoustic listening
Root mean square of the successive differences (RMSSD).of RR interval
Time frame: One hour after the acoustic listening
Root mean square of the successive differences (RMSSD).of RR interval
Time frame: During the acoustic listening
Total power spectrum (Ptot)
Time frame: During the acoustic listening
Total power spectrum (Ptot)
Time frame: One hour after the acoustic listening
Low Frequency (LF)
Time frame: During the acoustic listening
Low Frequency (LF)
Time frame: One hour the acoustic listening
High Frequency (HF)
Time frame: During the acoustic listening
High Frequency (HF)
Time frame: One hour after the acoustic listening
Very Low Frequency (VLF)
Time frame: During the acoustic listening
Very Low Frequency (VLF)
Time frame: One hour after the acoustic listening
Ratio Low Frequency (LF) / High Frequency (HF)
Time frame: During the acoustic listening
Ratio Low Frequency (LF) / High Frequency (HF)
Time frame: One hour after the acoustic listening
Heart rate (bpm)
Time frame: During the acoustic listening
Oxygen saturation (%)
Time frame: During the acoustic listening
NIPΣ index
Time frame: One hour after the acoustic listening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Premature Birth
Not yet recruiting
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Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugues PATURAL, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIPΣ index (time frame: During the acoustic listening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.