Clinical trial NCT04049526: The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Behavior
Infant Conditions
Infant Morbidity
Keywords: Music
Preterm infants
Heart Rate Variability
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Heart Rate Variability (HRV) variation in preterm infants according to different music genres listening
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Barbara Sgobbi
Study officials:
affiliation: Tincontro Onlus
name: Barbara Sgobbi
role: PRINCIPAL_INVESTIGATOR
References: