Panagiotis and Aglaia Kyriakou Childrens Hospital
Athens, Greece
NCT Number: NCT06398912
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.
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Notify Me28 week–32 week
All sexes
Interventional
Not applicable
Athens, Greece
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measuring how the fundamental frequency of differential music facilitators (mother, father, male and female music therapist) impacts the premature infant brain
Other names: Fundamental Frequency and Brain Development Intervention
Time frame: up to 18 months
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,
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Other
Acronym: FunFreqNICU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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