NCT06650189 Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)
| NCT ID | NCT06650189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of West Attica |
| Condition | Premature Neonates |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-07-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06650189 clinical trial?
This trial is open to participants of all sexes, aged 28 Weeks or older, up to 37 Weeks, studying Premature Neonates. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06650189 currently recruiting?
Yes, NCT06650189 is actively recruiting participants. Contact the research team at dmetallinou@uniwa.gr for enrollment information.
Where is the NCT06650189 trial being conducted?
This trial is being conducted at Athens, Greece, Chaïdári, Greece.
Who is sponsoring the NCT06650189 clinical trial?
NCT06650189 is sponsored by University of West Attica. The trial plans to enroll 70 participants.