Exploring how music affects the brain activity of premature infants in the NICU
Studying Newborns' Brain Activity in the NICU Through a Musical Intervention: the Role of Fundamental Frequency
This study is testing if playing structured music for premature babies in the NICU can positively change their brain activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 28 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | Athens General Children's Hospital "Pan. & Aglaia Kyriakou" Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT06398912 on ClinicalTrials.gov |
What this trial studies
This project investigates the impact of structured musical interventions on the brain activity of premature newborns in Neonatal Intensive Care Units (NICU). Using a randomized control trial design, infants born at or before 32 weeks of gestation will be assigned to either receive musical interventions or not, allowing researchers to evaluate the effects on their electroencephalographic (EEG) patterns. The study employs both quantitative EEG measurements and qualitative video recordings to capture the interactions between infants and music facilitators, aiming to uncover the therapeutic potential of music in neonatal care.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants born at or before 32 weeks of gestation who meet specific health criteria.
Not a fit: Patients who may not benefit from this study include those with severe health complications or conditions that contraindicate participation in musical interventions.
Why it matters
Potential benefit: If successful, this study could enhance neurodevelopmental interventions for premature infants, potentially improving their brain development outcomes.
How similar studies have performed: While the use of music-based interventions in neonatal care is a growing field, this specific approach focusing on EEG responses to musical stimuli in premature infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Athens
- Panagiotis and Aglaia Kyriakou Childrens Hospital — Athens, Greece (Recruiting)
Study contacts
- Study coordinator: Efthymios Papatzikis, Ph.D
- Email: efthymio@oslomet.no
- Phone: +4767237987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.