Development of Motility and Cognition in Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- neurological development
研究概览
简要总结
PILKE study uses wearables for assessing motor development in infants in order to define functional growth trajectories in the normal infants and infants at risk of neurological compromise. In addition, PILKE studies correlation of early motor development to later neurocognitive development.
详细描述
PILKE study builds on the recent development of an infant wearable, MAIJU, a multisensor garment that can be used to quantify infants posture and movement patterns out-of-hospital. The study will recruit typically developing infants (control group) and infants with an identified or suspected risk of neurodevelopmental compromise, as well as infants undergoing orthopedic follow-up for hip issues.
Infants will be examined and treated according to clinical routine practise, while MAIJU and other novel measures are added to monitor aspects of neurodevelopment. Recordings with MAIJU will be done every 6-8 weeks from about 5 months to 18 months of age, and the neuropsychological outcome is assessed using Bayley scales at two years of age.
The study is observational by design, and the trajectories of motor performance are compared to other clinically identified measures of development.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Months 至 26 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age at enrollment 5-8mos
- •typically developing
排除标准
- •all neurologically significant medical histories during pregnancy, at birth or postnatally
- •suspicion of developmental delay
- •suspicion or diagnosis of syndromes with neuromotor symptoms
结局指标
主要结局
neurological development
时间窗: 12 months
Binary information (normal vs abnormal) is taken from the postnatal follow-up clinic inspection that is done according to the national standards (www.thl.fi)
neurocognitive development
时间窗: 24 months
The total score of the neuropsychological examination Bayley scales III will be used
次要结局
未报告次要终点
研究者
Sampsa Vanhatalo
professor in clinical neurophysiology
Helsinki University Central Hospital