Understanding the Early Natural History of Cerebral Palsy - A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Musculoskeletal assessment
研究概览
简要总结
The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.
详细描述
This study aims to describe the early natural history of cerebral palsy (CP) by mapping the development of infants with, or at-risk of CP, over the first two years of life. Infants will be assessed at regular intervals up to 24 months of age, across a variety of childhood development to provide the first comprehensive developmental trajectories of this group. In doing so, it will contribute to the existing knowledge of CP development to assist clinicians and therapists with accurate information on prognosis and provide targeted interventions early and at the 'just-right' challenge. Where indicated, individual participants' results from this study will be used to inform their therapy. This study is intended to form part of a larger multi-site international study.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants will be included if they have a diagnosis of CP or "at high risk of CP" and under the age of 12 months.
- •Infants at high risk of CP as defined by any two (any combination) of the following:
- •Neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, Basal Ganglia, Posterior Limb of the Internal Capsule, pyramids.
- •Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age
- •Hammersmith Infant Neurological Exam (HINE) scores <57 @ 3months or <60 @ 6months or <63 @9 months
- •Infants will also be included if they meet BOTH of the following criteria (even if infants have a HINE score greater than the cut off scores stated above:
- •i. Unilateral brain injury on neuroimaging (magnetic resonance imaging (MRI) or cranial ultrasound (CUS)) predictive of CP ii. Clinical signs of asymmetry
排除标准
- •Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
- •Infants with other disability diagnoses e.g. Down Syndrome
结局指标
主要结局
Change in Musculoskeletal assessment
时间窗: 18 months, 24 months corrected age
Hip X-ray
Change in Speech and Language skills
时间窗: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Bayley Scales of Infant and Toddler Development
Change in Cognitive skills
时间窗: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Bayley Scales of Infant and Toddler Development
Change in Neurologic assessment
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Hammersmith Infant Neurological Examination
Change in Vision
时间窗: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Previas
Vision
时间窗: 3 months corrected age
Ricci
Change in Self Care
时间窗: 6 months, 12 months, 18 months, 24 months (corrected age)
Pediatric Evaluation of Disability Inventory Computerized Assessment Test
Change in Adaptive Behavior
时间窗: 12 months, 18 months, 24 months (corrected age)
Infant Toddler Social Emotional Assessment
Change in Parent Well Being
时间窗: 12 months, 18 months, 24 months (corrected age)
Depression, Anxiety and Stress Scale
Change in Motor skills
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Peabody: Gross and Fine motor skills
Change in Sleep
时间窗: 9 months, 12 months, 18 months, 24 months (corrected age)
Sleep disturbances Scale for Children
Change in Feeding skills
时间窗: 12 months, 18 months, 24 months (corrected age)
Dysphagia Disorder Survey
次要结局
未报告次要终点