A Randomized Clinical Trial of Infant Treadmill for Long-term Neurodevelopmental Evaluation of Neonatal Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- score from Bayley Scales of Infant and Toddler Development testing
研究概览
简要总结
There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigator will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.
详细描述
There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigators will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age < 33 weeks;
- •Correction of gestational age < 3 months;
- •It has been diagnosed as hypoxic-ischemic encephalopathy, periventricular intraventricular hemorrhage, periventricular leukomalacia, bilirubin encephalopathy, persistent hypoglycemia and cerebral infarction.
- •There was no other therapeutic intervention before entering the study;
- •Informed consent is signed by the family.
排除标准
- •This study is excluded from the study provided that one of the following conditions is met:
- •Brain injury caused by central or peripheral infection (cerebrospinal fluid positive / torch test positive / three major conventional culture positive);
- •Brain damage caused by convulsion;
- •Metabolic brain damage caused by genetic defects;
- •Suffering from known severe congenital malformations;
- •Definite head trauma during labor or postpartum;
- •Peripheral neuromuscular disease or abnormal skeletal system.
结局指标
主要结局
score from Bayley Scales of Infant and Toddler Development testing
时间窗: The length of time from birth to the corrected age of 18 months
These scores are largely used for screening, helping to identify the need for further observation and intervention, as infants who score very low are at risk for future developmental problems.
fractional anisotropy(FA)
时间窗: The length of time from birth to the corrected age of 18 months
a variable from Diffusion Tensor Image（DTI）sequence of MRI
the value of Amplitude of Low Frequency Fluctuation(ALFF)
时间窗: The length of time from birth to the corrected age of 18 months
a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI
次要结局
- Gross Motor Function Measure Scale(The length of time from birth to the corrected age of 18 months)
- Alberta Infant Motor Development Assessment(The length of time from birth to the corrected age of 18 months)
- mean diffusion(MD)(The length of time from birth to the corrected age of 18 months)
- Peabody motor development scale(The length of time from birth to the corrected age of 18 months)
- the value of regional homogeneity (ReHo)(Corrected age of 18 months)