Studying Newborns' Brain Activity in the NICU Through a Musical Intervention: the Role of Fundamental Frequency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Music Intervention
Participants will be exposed to an organized sound stimulus (music) during the EEG measurement
干预措施: Music Based Intervention (Other)
Control Group
Participants will not be exposed to an organized sound stimulus at any point of the EEG measurement
结局指标
主要结局
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
时间窗: 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,
次要结局
未报告次要终点
研究者
Dr Angeliki Nika
Neonatologist - Director of NICU
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"