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临床试验/NCT01889108
NCT01889108已完成1 期

Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Test of Infant Motor Performance

研究概览

简要总结

The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention practices in 2 important ways. First it bridges the traditional gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and intensive support for developmental activities when parents are establishing care giving routines. Second, in contrast to wide-ranging intervention provided by current early intervention models, SPEEDI uses an action perception model to target specific behaviors which lead to improved early motor abilities and provide a foundation for learning.[6] The purpose of this feasibility study is to extend the investigators preliminary data and evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of SPEEDI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • infants born preterm at 34 weeks Post Menstrual Age (PMA) or less
  • medically stable,
  • off ventilator support,
  • demonstrate thermoregulation in an open crib by 35 weeks of PMA,
  • live within 60 minutes of the hospital, and
  • have one parent who is English speaking and willing to participate in the study intervention and assessments

排除标准

  • genetic syndrome or
  • musculoskeletal deformity

结局指标

主要结局

Test of Infant Motor Performance

时间窗: Change from baseline to the end of intervention at 3 months of adjusted age

Assessment of motor development

Reaching

时间窗: end of intervention at 3 months of adjusted age

Reaching and object interaction measures

Problem Solving Behaviors

时间窗: end of intervention at 3 months of adjusted age

Early infant problem solving

次要结局

  • Parent Child Interactions(End of intervention at 3 months of adjusted age)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Feasibility Study of SPEEDI | 临床试验