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临床试验/NCT03742635
NCT03742635已完成不适用

Feasibility and Reliability of Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine

University of California, Davis2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2019年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
2
主要终点
Real-time versus video recording reliability

研究概览

简要总结

The investigators will implement a study to evaluate the hypothesis that applying General Movements Assessments (GMA) in a telemedicine setting with real-time scoring is feasible and comparable to scoring video recordings.

详细描述

The investigators hypothesize that using telemedicine to conduct the GMA will improve early identification of risk for cerebral palsy and facilitate earlier referral and access to neurodevelopmental intervention. Preterm birth results from complex interactions of biological and socioeconomic risk factors, all of which continue to influence neurodevelopmental trajectories beyond the prenatal and neonatal period. Unfortunately many of the socioeconomic factors that contribute to increased risk of prematurity are also associated with decreased likelihood to attend appointments at high risk infant follow-up (HRIF) clinics. Early intervention has been shown to be most beneficial to infants with highest social risk. Additionally, mothers living in more rural communities tend to have higher social risk. They are often younger, more likely to be a single parent, and have lower income. Helping make follow-up more accessible and convenient for families through telemedicine and at an earlier age using the GMA has the potential to improve early identification, minimize loss to follow-up and ensure prompt referral to optimize outcomes for the most vulnerable babies in this already high-risk population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
— 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • All preterm infants who meet the High-Risk Infant Follow Up (HRIF) Criteria (less than 32 weeks gestational age or birth weight less than 1500 grams) who are cared for at UC Davis Medical Center

排除标准

  • Families who are non-English speakers requiring a translator
  • Families who are unable to access data-capable wireless service to participate in telemedicine visits through Zoom.

结局指标

主要结局

Real-time versus video recording reliability

时间窗: 9 months gestational age

Intra-rater reliability of GMA (real-time versus video recording) will be assessed using the Kappa statistic.

次要结局

  • Video recording reliability(9 months gestational age)
  • Early referral(9 months gestational age)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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