Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 主要终点
- Change from baseline Test of infant motor performance at 3 months
研究概览
简要总结
This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.
详细描述
The perpose of this study to prove the significance of the hypothesis that there will be a significant improvement in motor development when remote tele-rehabilitation treatment is performed for extremely premature infants. The investigators plan to recruit subjects who meet the inclusion criteria and do not meet the exclusion criteria from among extremely premature infants born at Samsung Hospital, Seoul, Korea, whose gestational age is from 23 weeks to 28 weeks. The target number of n is 110, 55 per group. After randomization into an intervention group and a control group, the intervention group get the intervention starting at 0 months of correctional age and runs for 3 months. In both groups, motor outcomes are measured at the time of enrollment, at 3 months of correction age, 6 months of correction age and 12 months of correction age
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extreme premature baby (gestationl age 23~28 weeks)
- •Corrected age under one month at the time of enroll of this study
- •Children of those who voluntarily decided to participate after hearing detailed explanations about this study and gave their written consent.
- •Children whose parents are Korean
排除标准
- •Congenital anomalies in the central nervous system
- •Hereditary diseases
- •Chromosomal abnormalities (Down syndrome, etc.)
- •Stage 3 or more intraventricular hemorrhage
- •If surgery was performed for hydrocephalus
- •Leukomalacia confirmed by ultrasound examination (not applicable to increase in white matter shading)
- •Neonatal asphyxia
- •Other central nervous system diseases
- •If taking medications for convulsions or epilepsy
- •Metabolic disease
- •In the case of premature infants undergoing surgery for retinal disease
- •Hearing loss
- •In case of surgery due to complex congenital anomaly or planned operation (not excluded if surgery is not required)
- •In case of oxygen dependence due to lung disease in premature infants
- •Musculoskeletal disorders (hip dislocation, polyarthrosis, etc.)
- •Neuromuscular disease, etc.
- •Those whose family has social problems
- •Those whose parents cannot participate in this study
- •Those who have other serious complications that cannot proceed with the study
结局指标
主要结局
Change from baseline Test of infant motor performance at 3 months
时间窗: around the start of intervention(up to 1 week), 3 months after the start of intervetion
The Test of infant motor performance (TIMP) is conducted on infants under 4 months of age to perform functions in daily life. It is performed to evaluate the selective control of postures and movements that infants need in daily life, and takes an average of 25-35 minutes. The TIMP was developed to 1) identify infants with delayed motor development, 2) differentiate between infants with varying degrees of risk for measurement outcomes, and 3) measure changes due to interventions. Because it can be used in both early intervention programs, it can aid in communication between parents and health care providers in a variety of settings. The range of test score is from 0 to 142. The higher score means the better motor performance.
次要结局
- Change from baseline Edinburgh postnatal depression scale at 3 months(around the start of intervention(up to 1 week), 3 months after the start of intervetion)
- Alberta infant motor scale(6 months and 12 months after the start of intervetion)
- Peabody Developmental Motor Scales 2nd edition(12 months after the start of intervetion)
研究者
Jeong Yi Kwon
Professor
Samsung Medical Center