The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedFirst Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedAugust 9, 2019
August 1, 2019
5 months
August 6, 2019
August 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barbara Sgobbi
Varese, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Sgobbi
Tincontro Onlus
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Musicotherapist
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 8, 2019
Study Start
February 1, 2019
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
August 9, 2019
Record last verified: 2019-08