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临床试验/NCT02700646
NCT02700646已完成不适用

Improving Motor Skill Development in Infants After Cardiac Surgery

University of Michigan2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2016年1月5日最近更新:
适应症
干预措施

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

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

No Intervention

Standard care comparison

inpatient

Experimental

Inpatient recommendations to parents regarding infant motor activities

干预措施: Developmental recommendations (Behavioral)

inpatient

Experimental

Inpatient recommendations to parents regarding infant motor activities

干预措施: Standard care (Behavioral)

inpatient/outpatient

Experimental

Inpatient and outpatient recommendations to parents regarding infant motor activities

干预措施: Developmental recommendations (Behavioral)

inpatient/outpatient

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Uzark

Professor of Cardiac Surgery and Associate Professor of Pediatric Cardiology, Medical School

University of Michigan

研究点 (2)

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