The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns

Study Overview
=================
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.

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

Conditions
-----------------
Infant Behavior, Infant Conditions, Infant Morbidity

Intervention / Treatment
-----------------
* Behavioral: The influence of different music genres on Heart Rate Variability (HRV) in preterm infants


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 90 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: The influence of different music genres on Heart Rate Variability (HRV) in preterm infants|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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Music, Preterm infants, Heart Rate Variability