Early Physical Therapy Intervention in Preterm Infants During the Stay in the Neonatal Intensive Care Unit and at Home to Promote Motor Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Motor development.
研究概览
简要总结
The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age).
There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants.
The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age.
The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants, gestational age between 28-34 weeks
- •Families with ability to take care of the child, without chronic or mental illness
- •Long-term parental presence in the hospital (at least 10h/day)
排除标准
- •Children diagnosed with congenital disease or brain injury (LPV, HIV), before or during the study
- •Children undergoing major surgery (cardiac intervention, Ductus, thoracic intervention)
- •Children with musculoskeletal deformities
结局指标
主要结局
Motor development.
时间窗: 2 months corrected age and 8 months corrected age
Assessed by the Alberta Infant Motor Scale (AIMS). Total maximum score 40 points. Higher values represent a better outcome.
次要结局
- Mothers' stress index.(after the intervention, 3 months corrected age)
- Gross motor and fine motor function.(8 months corrected age)
- Movement quality.(40 weeks postmenstrual age and 2 months corrected age)
- Development and risk of development delay.(1 months corrected age and 8 months corrected age)
研究者
Mirari Ochandorena Acha
Physiotherapist, MSc, PhD St.
University of Vic - Central University of Catalonia