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临床试验/NCT03104751
NCT03104751已完成不适用

Neurodevelopment in Infants With Complex Congenital Heart Defects

Ohio State University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Change in Mobile Paradigm

研究概览

简要总结

The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with Complex Congenital Heart Disease (CCHD).

详细描述

The investigators' long-term goals are to develop a method of identifying infants likely to have adverse neurodevelopmental outcomes following neonatal treatment for CCHD and to develop and test interventions that can be applied early in infancy. The necessary first step is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with CCHD. Each measure provides unique information about development and will include (1) neuroimaging for brain maturity and brain injury, (2) hair and fingernails for cortisol and saliva for immune system function, (3) heart rate variability (HRV) for autonomic nervous system function (ANS), (4) Bayley Scales of Infant Development (BSID-III) for cognitive and motor function, (5) a naturalistic play session incorporating kicking, general movement analysis, or the Test of Infant Motor Performance (TIMP) for motor development, and (6) the mobile paradigm for learning, memory, and task-specific coordination. The investigators will look at types of relationships among these measures within each time point for description of development and across each time point for prediction of development. The investigators' core hypotheses are that infants with CCHD will have measurable deficits in cognitive and motor development birth to ~ 6 months of age when compared with a healthy control group and that a typology developed from neurodevelopmental measures will reliably predict cognitive and motor delay in the first six months of life in infants with CCHD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • at least 36 weeks gestational age
  • diagnosed with a Complex Congenital Heart Defect
  • have at least one English-speaking adult family member

排除标准

  • presence of co-existing, non-cardiac congenital anomalies
  • ongoing post-operative cardiac pacing

结局指标

主要结局

Change in Mobile Paradigm

时间窗: 3 months and 6 months

Measure of learning, memory, and task-specific kicking coordination in infants

Change in MRI (Magnetic Resonance Imaging) of brain - infants with CCHD only

时间窗: 1 to 5 days days prior to surgery, 4-10 days after surgery, 6 months of age

Brain MRI

Change in Heart Rate Variability

时间窗: 30 days, 3 months, 6 months

Measure of autonomic nervous system function and development

Change in Test of Infant Motor Performance (TIMP)

时间窗: 0-30 days, 3 months

test of early motor development

次要结局

  • State-Trait Anxiety Inventory(0-30 days, 3 months, 6 months)
  • Bayley Scales of Motor Development(3 months, 6 months)
  • Edinburgh Postnatal Depression Scale(0-30 days, 3 months, 6 months)
  • Infant-Toddler Quality of Life Questionnaire(0-30 days, 3 months, 6 months)

研究者

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

Jill Heathcock

Associate Professor

Ohio State University

研究点 (1)

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