Actively Recruiting
Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)
Led by University of West Attica · Updated on 2025-04-01
70
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of West Attica
Lead Sponsor
G
General and Maternity Hospital of Athens Elena Venizelou
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this prospective randomized clinical trial is to investigate the effect of music intervention on the stress of live born preterm neonates requiring admission to a Neonatal Intensive Care Unit, through the measurements of salivary biomarkers (hormones and proteins). The main question it aims to answer is: Can the daily music intervention reduce the stress levels created by the Neonatal Intensive Care Unit environment in preterm neonates? Researchers will compare preterm neonates who will not be exposed to music intervention to investigate potential discrepancies in salivary stress biomarkers. Participants will be exposed to recorded music for 5 consecutive days.
CONDITIONS
Official Title
Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born between 28 - 36+6 weeks of gestation
- Absence of active infection including blood, urine, cerebrospinal fluid
- Absence of congenital and genetic disorders and chromosomal abnormalities
- Absence of nuclear jaundice
- Absence of endocrine disorders
- Absence of maternal use of illicit drugs prenatally
- Non - sedated neonates
- Positive bilateral transient evoked otoacoustic emissions
- Stable clinical condition
- Absence of brain injury
You will not qualify if you...
- Diagnosis of brain injury after the enrollment
- Negative auditory brainstem response before discharge
- Clinical deterioration
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Trial Site Locations
Total: 2 locations
1
General and Maternity Hospital of Athens Elena Venizelou
Athens, Greece, 11521
Actively Recruiting
2
Attikon General University Hospital
Chaïdári, Greece, 12462
Not Yet Recruiting
Research Team
D
Dimitra Metallinou, Assistant Professor
CONTACT
M
Maria Tzeli, PhD candidate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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