Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398912
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-23
Brief Title:
Studying Newborns Brain Activity in the NICU Through a Musical Intervention the Role of Fundamental Frequency
Sponsor:
Oslo Metropolitan University
Organization:
Oslo Metropolitan University
Study Overview
Official Title:
Studying Newborns Brain Activity in the NICU Through a Musical Intervention the Role of Fundamental Frequency
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FunFreqNICU
Brief 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
Detailed Description:
Research Design and Methodology
Adopting an exploratoryrandomized 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 interventions 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 interventions 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 stimulis 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
Adopting an exploratoryrandomized 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 interventions 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 interventions 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 stimulis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None