Predicting and Monitoring Motor Development of Children Requiring Surgery as Neonates for Complex Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Motor development at 18 months
研究概览
简要总结
Infants requiring surgery in the neonatal period for complex congenital heart diseases are at risk for developmental problems. For infants with congenital heart diseases with admixture physiology and single ventricles, optimal circulation is associated with signs of adequate systemic perfusion and a systemic arterial oxygen saturation typically between 75% to 90%. Infants are often unable to withstand standardized developmental testing during early infancy due to medical fragility and sternal precautions after surgery. Evaluation of the quality of spontaneous movements and movement variability is a good alternative. The quality of general movements in early infancy is a valid predictor of neurological disorders in high risk infant groups and is assessed with short periods of video-recorded observations. This methodology has yet to be studied in infants with complex congenital heart disease that require surgery as neonates. For older infants, the Infant Motor Profile (IMP) is a promising tool to document developmental outcome.
详细描述
Congenital heart defects (CHD) are conditions present at birth and affect heart structure, function, and manner in which blood flows through the heart and to the rest of the body. The incidence of severe CHD is about 2.5 to 3/1,000 live births. With improvements in cardiac surgical technique and critical care medicine, the vast majority of babies with CHD are expected to survive to school age and beyond. However, these surgical and medical advances are also associated with increased risk for neurodevelopmental morbidity.
Traditionally, a quantitative approach measured gross motor development of infants at risk for delay, including children with complex congenital heart disease. These tools emphasize elicited responses; however, clinical use and validity may be limited by the infant's behavioral state, unstable physiological status, intolerance of handling, or sternal/surgical precautions. Alternatively, European clinicians working in the field of developmental neurology realized that variation and adaptability in motor behavior may assist in the evaluation of motor development. The application of motor variation and adaptability as a means to evaluate neuromotor condition in early infancy was significant for early detection of infants at high risk for developmental problems or cerebral palsy in a number of studies with high-risk infant groups. This form of evaluation has yet to be studied in infants with complex congenital heart diseases.
The proposed study aims to study motor development of two infant groups based on oxygen saturation targets after neonatal surgery and to study the validity of the assessment tools based on the quality of movement variation and adaptability, i.e., the General Movements Assessment (GMsA) and the Infant Motor Profile (IMP) in infants with complex congenital heart disease.
Hypothesis:
Baseline oxygen saturation after neonatal heart surgery in children with complex congenital heart diseases is a determinant of motor performance outcome at 18 months on the Infant Motor Profile.
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
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants diagnosed with complex congenital heart diseases that require surgery during the neonatal period, ages 0-30 days
- •Surgical care at Advocate Christ Medical Center/Advocate Children's Hospital, Oak Lawn, Il
排除标准
- •Chromosomal abnormalities and/or known syndromes
结局指标
主要结局
Motor development at 18 months
时间窗: 18 months
Comparison of motor development of two groups of infants based on oxygen saturation targets after neonatal surgery using the Infant Motor Profile
次要结局
- Concurrent validity(18 months)
- Movement quality from birth to 4 months of age(4 months. The infant's general movements are video-recorded three to five times from birth to four month according to this schedule: pre-operation (if possible), hospital discharge, one month of age, two months of age, and three months of age)
- Cognitive and language development at 18 months(18 months)