Improving Motor Skill Development in Infants After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Gross Motor Scale score
研究概览
简要总结
The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life.
详细描述
Congenital heart disease (CHD) and the need for life-saving heart surgery and intensive care during infancy may have effects on infant behavior and development. Children who require open heart surgery before their first birthday are vulnerable to developmental delays, especially related to motor skills (mobility) in the first year of life. Early delays in gross motor functioning (e.g., rolling, crawling, walking) have implications for learning and psychosocial development through adulthood. To date, no interventions to improve the gross motor functioning of children born with CHD have been developed. The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life. Activities will be tailored based on the individual infant's motor ability and medical status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 120 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All hospitalized infants under age 4 months having cardiac surgery before age 3 months
- •Intubation >/= 24 hours </= 14 days
排除标准
- •Prematurity </= 36 weeks gestation
- •Pre-operative clinical evidence of a central nervous system (CNS) anomaly or history of CNS insult
研究组 & 干预措施
standard care
Standard care comparison
inpatient
Inpatient recommendations to parents regarding infant motor activities
干预措施: Developmental recommendations (Behavioral)
inpatient
Inpatient recommendations to parents regarding infant motor activities
干预措施: Standard care (Behavioral)
inpatient/outpatient
Inpatient and outpatient recommendations to parents regarding infant motor activities
干预措施: Developmental recommendations (Behavioral)
inpatient/outpatient
Inpatient and outpatient recommendations to parents regarding infant motor activities
干预措施: Standard care (Behavioral)
结局指标
主要结局
Gross Motor Scale score
时间窗: 3 months after hospital discharge
Alberta Infant Motor Scale (AIMS) score
次要结局
未报告次要终点
研究者
Karen Uzark
Professor of Cardiac Surgery and Associate Professor of Pediatric Cardiology, Medical School
University of Michigan
