跳至主要内容
临床试验/NCT04287166
NCT04287166进行中(未招募)不适用

Feasibility of Remote Early At-risk Diagnosis for Cerebral Palsy in High-risk Infant Follow-up Clinics in The Central Norway Regional Health Authority

St. Olavs Hospital3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
3
主要终点
Predictability of GMA and computer-based assessment for development of CP

研究概览

简要总结

Cerebral Palsy (CP) is the most common motor dysfunction in childhood. Traditionally, diagnosis is set between 12 and 24 months of age. This study will evaluate feasibility of a new screening procedure for early detection of CP in high-risk infants and investigate how such a procedure can be implemented in the Central Norwegian Regional Health Authority (CNRHA).

The most accurate method to detect and predict CP at an early age is the General Movement Assessment (GMA). GMA is based upon expert observations of infant spontaneous movements in a video. In Central-Norway such expertise is today only present at St. Olavs Hospital, Trondheim University Hospital. Video recordings by health personnel and parents will be used in follow-up programs within CNRHA for remote expert based GMA. In addition, machine learning models will be applied for automatic detection of CP.

Early identification of CP will lead to improved function and increased possibility to direct health care resources to the patients who need it most, independent of geographical and expert based constraints.

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
0 Months 至 2 Months(Child)
性别
All
接受健康志愿者

入选标准

  • hospitalized at a Neonatal Intensive Care Unit (NICU) within the Central Norway Regional Health Authority that is referred to follow-up in the Specialist Health Services containing a team of minimum a pediatrician and a physiotherapist.
  • at high-risk for adverse neurological outcomes as considered by the pediatrician on the basis of clinical judgement (example: serious asphyxia, prematurity, stroke, brain hemorrhage)

排除标准

  • Peripheral neuromotor disease e.g. brachial plexus injury
  • iatrogenic restricted movements (e.g. cast for clubfoot)

结局指标

主要结局

Predictability of GMA and computer-based assessment for development of CP

时间窗: 5 years

Correlation of computer software data between standard video set-up and handheld smartphone video.

时间窗: 1 week

Scorable video for remote GMA

时间窗: 1 week

Predictability of GMA and computer-based assessment for development of CP

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (3)

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