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Recruiting NCT06650189

Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)

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Trial Parameters

Condition Premature Neonates
Sponsor University of West Attica
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 28 Weeks
Max Age 37 Weeks
Start Date 2024-07-01
Completion 2026-07
Interventions
Music intervention

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosis of brain injury after the enrollment * Negative auditory brainstem response before discharge * Clinical deterioration

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