An interventional study of Music Based Intervention in Premature Birth, sponsored by Athens General Children's Hospital "Pan. & Aglaia Kyriakou". Completed at 1 site in Greece. Open to participants aged 28 Weeks to 32 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Athens General Children's Hospital "Pan. & Aglaia Kyriakou" · Not applicable, Interventional, and Supportive care
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.
Research Design and Methodology
Adopting an exploratory/randomized control trial (RCT) design, this study is meticulously planned to evaluate the effects of musical interventions on premature infants housed within a NICU setting. Therefore, participants, specifically newborns born at ≤ 32 weeks of gestation who meet stringent inclusion criteria, are randomly assigned to either an intervention group that receives structured musical interventions for a week or a control group that does not receive any musical stimulation. This methodological approach ensures a controlled examination of the intervention's efficacy, attributing observed neurophysiological changes directly to the musical stimuli.
Data Collection Protocol
The data collection protocol employs a dual approach: quantitative EEG for capturing the infants' brain activity and qualitative video recordings to document the dynamic interactions between the infants and the music facilitators. This multifaceted strategy ensures a comprehensive analysis of the effects of musical interventions, facilitated by a diverse group of individuals including male and female music therapists, and the infants' parents. Such diversity allows for a nuanced exploration of how different human profiles influence the intervention's impact on brain activity patterns.
Tools for Data Collection
The primary instrument for data collection is an 6-channel EEG system, chosen for its precision in measuring the complex electrical dynamics of the infants' brains. This is complemented by a high definition video camera that aims to capture the qualitative dimensions of the intervention, such as the infants' behavioral responses and the nuanced interaction dynamics between the infant and the facilitator. Together, these tools promise a holistic dataset that bridges the gap between neurophysiological and behavioral observations.
Data Analysis Protocol
The data analysis framework is comprehensive, incorporating (tentatively) a Repeated Measures Analysis of Variance (ANOVA) to scrutinize brain activity across different conditions, facilitators and qEEG features. This is to dissect the EEG data across the available condition variables, identifying specific patterns and variations indicative of the musical stimuli's impact.
Significance and Expected Outcomes
By melding advanced methodological design with innovative data collection and analysis techniques, the project is uniquely positioned to elucidate the neurodevelopmental benefits of musical interventions for premature infants in the NICU environment.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 31 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Athens General Children's Hospital "Pan. & Aglaia Kyriakou" is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants will be exposed to an organized sound stimulus (music) during the EEG measurement
Other: Music Based Intervention
Participants will not be exposed to an organized sound stimulus at any point of the EEG measurement
Measuring how the fundamental frequency of differential music facilitators (mother, father, male and female music therapist) impacts the premature infant brain
Also known as: Fundamental Frequency and Brain Development Intervention
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
a predefined set of qEEG features (rEEG, coherence, spectral power etc) will be measured and analyzed via a 6 channels EEG unit in the NICU,
Time frame: up to 18 months
Plan to share: Undecided
Ran from Apr 2023 to primary completion in Jul 2025, 27 months.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 27 months is above that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Athens General Children's Hospital "Pan. & Aglaia Kyriakou"