Infant BehaviorNCT04049526
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
An observational study of Infant Behavior and Infant Conditions, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
Trial summary
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants. Neonates undergo a daily randomized music listening program. An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure. Read more about this study
- Who is it for?
- Ages 1 day to 90 days
- Conditions the study is for
- Infant Behavior, Infant Conditions, Infant Morbidity
- What is being tested?
- The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 30 Jun 2019
- 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 1 day to 90 days
- All sexes
- No healthy volunteers
- Child
Study population: Enrollment performed when sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the test
Who may be able to join
- gestational age between the 23th and the 32nd week
- birth weight <1500g
- appropriate for gestational age, sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the test
Who cannot join
- genetic anomalies, chromosomal aberrations, congenital heart malformations, intraventricular haemorrhage (> grade II on ultrasound), periventricular Leukomalacia
- neonates with failed responses to bilateral hearing screening performed by Automated Auditory Brainstem Response testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Premature Newborns: An Italian Pilot Study
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants.
Neonates undergo a daily randomized music listening program. An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.
Read the detailed description
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants.
HRV has been previously used to evaluate autonomic nervous system fluctuations in heart rate related to maturation in healthy neonates and in neonates with pathological conditions. This parameter has been used to show how music could improve well-being and the development of the autonomic nervous system in infants.
In this study, neonates (see also inclusion/exclusion criteria), recruited on the basis of birth order, undergo a daily randomized music listening program (25 minutes, every day, for 3 days) based on different music genres listening (soft pop-rap, pop-rock and classical music). Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.
- Conditions
- Infant Behavior, Infant Conditions, Infant Morbidity
- Being tested
- The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
- Keywords
- Music, Preterm infants, Heart Rate Variability
- Medical subject headings
- Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The influence of different music genres on Heart Rate Variability (HRV) in preterm infantsBehavioural
Neonates undergo a daily randomized music listening program (25 minutes, every day, for 3 days) based on different music genres listening (soft pop-rap, pop-rock and classical music). Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV) variation in preterm infants according to different music genres listening
An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.
Measured: Enrollment performed when sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Feb 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant BehaviorStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale di Circolo - Fondazione Macchi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Sgobbi, Ospedale di Circolo - Fondazione Macchi
- Investigators
- Barbara Sgobbi, Principal investigator, Tincontro Onlus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049526
- Sponsor's protocol ID
- 51
- Status last verified
- May 2026
- First submitted
- 6 Aug 2019
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Premature Newborns: An Italian Pilot Study
- ClinicalTrials.gov ID
- NCT04049526
- Acronym / sponsor ID
- 51
- Conditions
- Infant Behavior, Infant Conditions, Infant Morbidity
- Keywords
- Music, Preterm infants, Heart Rate Variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 8 Aug 2019 (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.
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants.
Neonates undergo a daily randomized music listening program. An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.
Detailed description
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants.
HRV has been previously used to evaluate autonomic nervous system fluctuations in heart rate related to maturation in healthy neonates and in neonates with pathological conditions. This parameter has been used to show how music could improve well-being and the development of the autonomic nervous system in infants.
In this study, neonates (see also inclusion/exclusion criteria), recruited on the basis of birth order, undergo a daily randomized music listening program (25 minutes, every day, for 3 days) based on different music genres listening (soft pop-rap, pop-rock and classical music). Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Enrollment performed when sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the test
Key inclusion criteria (3 listed)
- gestational age between the 23th and the 32nd week
- birth weight <1500g
- appropriate for gestational age, sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the test
Key exclusion criteria (2 listed)
- genetic anomalies, chromosomal aberrations, congenital heart malformations, intraventricular haemorrhage (> grade II on ultrasound), periventricular Leukomalacia
- neonates with failed responses to bilateral hearing screening performed by Automated Auditory Brainstem Response testing
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 |
|---|---|---|
| The influence of different music genres on Heart Rate Variability (HRV) in preterm infantsNeonates undergo a daily randomized music listening program (25 minutes, every day, for 3 days) based on different music genres listening (soft pop-rap, pop-rock and classical music). Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure | Behavioural | – |
Primary outcome
Heart Rate Variability (HRV) variation in preterm infants according to different music genres listening
Time frame: Enrollment performed when sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the treatment
An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.
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 26 May 2026.
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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.
Barbara Sgobbi principal investigator
Tincontro Onlus
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 Infant Behavior and Infant Conditions, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
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 3 inclusion and 2 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 26 May 2026. 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 Italy. 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?
Heart Rate Variability (HRV) variation in preterm infants according to different music genres listening (time frame: Enrollment performed when sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the treatment). 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 26 May 2026.