Studying Newborns' Brain Activity in the NICU Through a Musical Intervention: the Role of Fundame… (NCT06398912) | Clinical Trial Compass
CompletedNot Applicable
Studying Newborns' Brain Activity in the NICU Through a Musical Intervention: the Role of Fundamental Frequency
Greece31 participantsStarted 2023-04-20
Plain-language summary
This research project stands to the intersection of neonatology, neuroscience, and music based interventions (MBIs), exploring the impact of structured sound on the brain activity of premature newborns in Neonatal Intensive Care Units (NICU). It embarks on a pioneering investigation to decipher how variations in musical stimuli, particularly those that differ in human profiles (gender and kinship) and fundamental frequencies, affect the short-term electroencephalographic (EEG) footprint of these vulnerable infants. The project aims to uncover profound insights into the therapeutic potential of music within neonatal care, thereby advancing our understanding of neurodevelopmental interventions for premature infants.
Who can participate
Age range
28 Weeks – 32 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Born at (equal or less than) 32 weeks of gestation
* Absence of auditory insufficiency in the 8th cranial nerve and excessive pathology in the brainstem
* Negative bilateral "transient evoked otoacoustic emissions," indicating unresponsiveness of the inner ear to an acoustic stimulus.
* Weighing 1000 grams or more
* In stable health conditions with no imminent risk of death
* Not sedated
* Absence of neonatal sepsis.
* No congenital, genetic, or chromosomal abnormalities.
* No nuclear jaundice.
* No maternal use of illicit drugs during pregnancy.
* No necessity for mechanical ventilation that creates excessive noise (i.e., high-frequency oscillatory ventilation).
* No need for sedative drug administration to the neonate.
* Absence of endocrine disorders (e.g., congenital hypothyroidism).
Exclusion Criteria:
* If a newborn is diagnosed with a disease or dysfunction during the study and the medical staff recommends their removal, they will be automatically excluded from the recruited sample.
* Use of other music stimulation during the implementation of the intervention period
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
qEEG features changes before, during and after the delivery of the musical intervention correlated to the fundamental frequency of the signing voice of the music facilitators
Timeframe: up to 18 months
Trial details
NCT IDNCT06398912
SponsorAthens General Children's Hospital "Pan. & Aglaia Kyriakou"