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