Neurodevelopment in Infants With Complex Congenital Heart Defects
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
- 是
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
Jill Heathcock
Associate Professor
Ohio State University
