NCT03689725Unknown不适用
The Effect of Music on Functional Processing and Structural and Functional Development of the Preterm Infant's Brain
Pediatric Clinical Research Platform2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Compare resting state maturation in the three groups using resting state fMRI
研究概览
简要总结
Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 33 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants: 33 weeks < gestational age < 37 weeks
- •Full-term newborns: 37 weeks gestational age < 42 weeks
排除标准
- •Neurological issues or malformations (such as III-IV stade Intraventricular hemorrhage, micro or macrocephaly, hydrocephaly...)
- •Because of the high noise caused by nasal continuous positive airway pressure (nCPAP), preterm newborns without at least nCPAP pause before 32 6/7 gestational age will be excluded
结局指标
主要结局
Compare resting state maturation in the three groups using resting state fMRI
时间窗: 40 weeks gestational age
An MRI will be conducted at term or term equivalent age including resting state functional magnetic resonance imaging (fMRI) measures.
Compare structural maturation in the three groups using structural MRI and DTI
时间窗: 40 weeks gestational age
An MRI will be conducted at term or term equivalent age including structural Magnetic Resonance Imaging and Diffusion Tensor Imaging (DTI) measures.
次要结局
- The music intervention effect on effortful control at one and two years of age(at 2 years of age)
- Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using fMRI(40 weeks gestational age)
- The music intervention effect on cognitive language and motor development at one and two years of age(at 1 and 2 years of age)
- The music intervention effect on emotion and temperament at one and two years of age(at 1 and 2 years of age)
- Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using EEG(40 weeks gestational age)
研究者
研究点 (2)
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