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临床试验/NCT04622787
NCT04622787Enrolling By Invitation不适用

Implementation of Early Detection and Early Intervention Service Delivery in Infants at Risk for Cerebral Palsy to Promote Infants' Psychomotor Development and Maternal Health

University of Pisa1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
500
试验地点
1
主要终点
Knowledge Translation effectiveness

研究概览

简要总结

The BORNTOGETTHERE consists of improving health programs for early detection and surveillance of Cerebral Palsy (CP) by implementing the first International Clinical Practice Guidelines (Novak et al, 2017) in multiple sites in Europe (Italy, Denmark, Netherlands), in low- and middle-income countries (Georgia, Sri Lanka) and hard to reach populations (Remote Queensland, QLD and Western Australia, WA). In addition, exploiting early detection of infants at very high risk of CP, the investigators will implement best-evidence knowledge on early intervention in CP, thereby improving the outcomes of the infants and of their caregivers.

详细描述

The overall aim of the study is to utilize Knowledge Translation strategies to disseminate culturally appropriate guidelines for early detection, surveillance, and early intervention for infants at risk for CP.

Primary objectives A1 To optimize the context-specific health programs for early detection of CP through the implementation of a tailored multifaceted knowledge translation strategy, in >500 infants with CP from Tuscany (Italy); Denmark; Netherlands, Georgia, Sri Lanka, and rural/ remote Australia (QLD, WA).

The investigators will also evaluate health care resource usage following the implementation of our translation strategy compared with a two-year period prior to the implementation- e.g. costs of early detection and targeted surveillance, targeting infants with CP (costs and consequences/outcomes of surveillance and intervention).

H1 Our hypothesis is that, compared with usual care, implementation of our translation strategy will increase the proportion of children that receive a diagnosis of CP <6 months of age from ~25% to >60%, as measured by CP Registers. Additional costs of screening and surveillance in our translation strategy will be off-set by targeting the highest risk babies earlier. Health care costs and usage will be focused on the most at-risk group, leading to improved outcomes across all children (costs/consequences analysis).

A2 To optimize the context-specific health programs for early surveillance of associated impairments and functional limitations of infants with CP, thereby fostering individualised (needs-based patient specific) early intervention and preventing secondary complications (e.g. hip dislocation, feeding disorders). The investigators will evaluate the early developmental trajectory of CP in infants aged 0-2 years and parental mental health to inform early intervention and surveillance needs to improve prediction of outcomes. The investigators will also compare the rates of hip displacement at 2 years following the implementation of our translation strategy compared with usual care (i.e. proportion of children with migration percentage >30%).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Medical/healthcare provider or advanced trainee
  • Works with infants at risk or with diagnosis of cerebral palsy
  • Practices in Georgia, Sri-Lanka, The Netherlands, Denmark, Remote Queensland region of Australia, Tuscan region of Italy,

排除标准

  • Not a healthcare provider or trainee
  • Located (practicing) outside of study country locations
  • Infant and family observational study:
  • Inclusion criteria: Infants aged <12 months' corrected age at with one of the following
  • Extremely preterm
  • Extremely low birthweight
  • Neonatal encephalopathy
  • Abnormal General Movements with abnormal brain neuroimaging
  • Abnormal General Movements with abnormal Neurological Evaluation
  • Abnormal brain neuroimaging with abnormal Neurological Evaluation
  • Exclusion criteria
  • Lethal abnormalities
  • congenital conditions not associated with cerebral palsy (e.g. Down's Syndrome)
  • complex medical conditions requiring acute medical care

结局指标

主要结局

Knowledge Translation effectiveness

时间窗: through study completion, an average of 3 years

Clinicians will be tested in survey format on their knowledge of the guidelines

次要结局

  • Infant age at diagnosis of Cerebral Palsy(through study completion, an average of 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Guzzetta

Associate Professor

University of Pisa

研究点 (1)

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