Singing Kangaroos - Infant Care With Combined Auditory Intervention and Kangaroo Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Auditory cortical responses
研究概览
简要总结
To assess whether a musical intervention (maternal/paternal singing) during the skin-to-skin sessions (Kangaroo care) would improve the language development of the preterm infant. Infants will be randomized to singing or silence during the Kangaroo care from the age corresponding to 30th gestational week until term age (40 gestational weeks).
详细描述
The outcomes are:
a 2- (3-)year neurodevelopmental follow up
- Bayley Scales of Infant and Toddler Development, Third Edition (in Finnish in Finland and in Swedish in Sweden)
At the age corresponding to term (40 gestational weeks)
- Auditory event related potentials (AERPs) in electroencephalography (EEG), in Helsinki cohort
- Auditory event related magnetic fields in magnetoencephalgraphy (MEG) in Karolinska cohort
- Parental stress with The State Trait Anxiety Inventory (STAI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors do not know the intervention that took place before outcome assessed
入排标准
- 年龄范围
- 7 Days 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants at 30th gestational week capable of being in Kangaroo care
排除标准
- •intensive care preventing Kangaroo care
结局指标
主要结局
Auditory cortical responses
时间窗: Age corresponding to term, ie 40 gestational weeks
Auditory Event-Related Potentials (AERPs) at full-term age will be recorded with multi-feature paradigm (MFP), in which the mismatch negativity (MMN) to 5 speech-related auditory features can be recorded in a short time period.
Parental anxiety
时间窗: 3 months age
Parents' state anxiety is measured using the STAI (State-Trait Anxiety Inventory, Spielberger, 1983) with 20 self-descriptive statements once per week until the infant leaves the hospital and once in two weeks until the infant reaches the corrected age of 3 months,
次要结局
- Neurocognitive development, language development(2 year of age)
研究者
Vineta Fellman
professor
University of Helsinki