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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04049526
Other study ID # 51
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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