Development of a Developmental Prognostic Tool for the Premature Child Based on Automated Spontaneous Motor Analysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Automatized quantification of complexity of general movements (spatial variation).
研究概览
简要总结
Prematurity is a major risk factor for poor neurodevelopmental outcomes. The clinical and neuroradiological evaluations proposed during the neonatal period to assess the developmental prognosis of children born prematurely are not sensitive and nor specific. The analysis of spontaneous motor activity by Prechtl's method has a better predictive value but is currently unfeasible in clinical routine. The study's principal objective is to describe the standardized values of complexity, variability, and fluidity of general movements.
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
- 1 Day 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth before 33 week of amenorrhea;
- •Hospitalization in the Neonatal Department of the Saint-Étienne University Hospital
- •Patient affiliated or entitled to a social security scheme;
- •Authorization to shoot the holders of parental authority;
- •Consent to participate in the study by the holders of parental authority
排除标准
- •Need for ventilatory support;
- •Difficulty of thermal regulation contraindicating the use of a heating cradle;
- •Refusal of authorization to shoot by holders of parental authority;
- •Refusal of participation in the study of holders of parental authority.
结局指标
主要结局
Automatized quantification of complexity of general movements (spatial variation).
时间窗: Year: 3
Measured by analyze of all acquisitions.
Automatized quantification of variability of general movements (temporal variations)
时间窗: Year: 3
Measured by analyze of all acquisitions.
Automatized quantification of fluidity of general movements (uniform distribution)
时间窗: Year: 3
Measured by analyze of all acquisitions.
次要结局
- Comparison between our quantitative analysis and qualitative analysis according to the reference method of Pretchl(Year: 3)