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临床试验/NCT05907837
NCT05907837招募中不适用

Early Detection & Intervention of Cerebral Palsy in Ireland

University College Cork5 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,500
试验地点
5
主要终点
Standardised Approach to Assessing infant at risk of CP

研究概览

简要总结

Cerebral palsy (CP) is the most common lifelong physical disability. It is defined as a non-progressive disorder of movement originating from neural lesions in the perinatal period, and is associated with a wide range of common comorbidities in many individuals. These include problems speaking, hearing, seeing, thinking, feeding and controlling their bladder. People with CP often have additional challenges such as behavioural and emotional issues, pain, and poor sleep. Many of these challenges respond well to intervention in early childhood, as brain plasticity is at its greatest in the first 2 years of life. However, in most clinical settings, the age for diagnosis of CP is between 24 to 29 months, after this window of neurodevelopmental opportunity.

This project will aim to improve the Early Detection of Cerebral Palsy in Ireland. This will be achieved by implementing an evidence-based approach to follow-up of High risk infants.

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
— 至 40 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
  • All infants considered high risk for cerebral palsy and neuro-developmental impairment will be eligible, specifically including:
  • All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight
  • All encephalopathic infants
  • Neurological risk factors (e.g., injury/malformation on neuroimaging, persistently abnormal neurological exam)

排除标准

  • Death prior to discharge from the neonatal unit.

结局指标

主要结局

Standardised Approach to Assessing infant at risk of CP

时间窗: 5 years

To establish a standardised approach to assessing infants at risk of CP in High Risk Follow-up Clinics across Ireland.

Reduce the age of CP diagnosis in Ireland.

时间窗: 5 years

Reduce the age of diagnosis of cerebral palsy in Ireland to less than 12 months of age by using evidence based standardised motor and neurological assessments at set time points.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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