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

Infant Behavior Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049526
• Other study ID #: 51
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Ospedale di Circolo - Fondazione Macchi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Infant Behavior
• Infant Conditions
• Infant Morbidity

Intervention

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

Locations

Country	Name	City	State
Italy	Barbara Sgobbi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale di Circolo - Fondazione Macchi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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