Effects of Early Intervention for Preterm Children at School Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Child neurobehavioral development
研究概览
简要总结
Despite the remarkable achievements in neonatal survival of preterm infants with very low birth weight (VLBW, birth weight < 1,500 g) over the past three decades, improvements have produced little change in their prevalence of severe developmental disability and the rate of low severity dysfunctions (e.g., learning disabilities, low IQ, attention-deficit hyperactivity disorder, specific neuropsychological deficits, poor perceptual-motor skills and internalizing behavioral problems) remains high as 50% to 70%. Few intervention programs developed for preterm infants in Western societies were shown to have short- to long-term benefits in certain cognitive functions, however, rare studies have investigated intervention effect at school age and explored plausible neurological pathway for effective intervention. This three-year study was therefore aimed to extend our previous research to longitudinally examine the effectiveness of three intervention programs (clinic-based intervention program [CBIP], home-based intervention program [HBIP] and usual care program [UCP]) for VLBW preterm children in Taiwan at seven years of age.(The intervention had been delivered from birth to one year of corrected age in the previous study. The intervention will not be given in this study.)The CBIP and HBIP contained similar child- and parent-focused services as well as interaction activities but were respectively delivered at the clinic for the CBIP and at home for the HBIP. A total of 178 VLBW preterm infants had been randomly assigned to the CBIP, HBIP or UCP. Sixty-two gender and maternal education level matched term children with normal birth weight had also been included to serve as the reference group for comparison of developmental outcomes. Effectiveness examined included child and parent outcomes. The long-term effect of the early intervention for preterm children would provide important information to help medical professionals and public policy makers to develop an effective intervention for Taiwanese preterm children who are at risk of developmental disorders.
详细描述
Specific Aims:
This study was to extend our previous research to longitudinally examine the effectiveness of three intervention programs (CBIP, HBIP and UCP) for VLBW preterm children in Taiwan at seven years of age. Gender and maternal education level matched term children were also included to serve as the reference group for comparison of developmental outcomes. The intervention had been delivered from birth to one year of corrected age in the previous study. Effectiveness examined including children's and parental outcomes. Primary outcome referred to measures of child neurobehavioral functions. Neurobehavioral assessment included cognitive, motor and behavioral measurement. Secondary outcomes referred to child growth and health, neurophysiological functions, and the quality of parenting measures. Neurophysiological assessment referred to electroencephalogram/event-related potential examinations that were used to investigate the neurological pathways underlying the effective intervention.
Subjects and Methods:
Participants:
One hundred and seventy-eight VLBW preterm children and 62 term children who had participated in our previous study were enrolled in this study. VLBW preterm children were born or admitted at the National Taiwan University Hospital, the Mackay Memorial Hospital and Taipei City Hospital, Branch for Women and Children in Taipei, Taiwan, during the time period of 2006 to 2008.
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
- 7 Years 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Child neurobehavioral development
时间窗: at 7 years of age
Child neurobehavioral assessment including cognitive and, motor, and behavior functions. Cognitive functions were assessed by the intelligence (IQ test), the efficiency of attention control (sustained attention test), and the cognitive flexibility and planning (executive function test). Motor functions assessment included motor skill acquisition and coordination. Child's behavior was measured by the parent/teacher reported questionnaire (two different versions) of child's adaptive behavior in the school context.
次要结局
- Child neurophysiological functions(at 7 years of age)
- Child growth-height(at 7 years of age)
- Child health condition(at 7 years of age)
- Child growth-weight(at 7 years of age)
- Parenting(at 7 years of age)
- Child educational resources(at 7 years of age)
