Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Child: Neurodevelopment- The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition
研究概览
简要总结
This study is to extend our previous research to longitudinally examine the effectiveness of intervention programs (FCIP and UCP) for VLBW preterm children in Taiwan at seven years of age. Gender and maternal education level matched term children will also be 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 will include child and parent outcomes. Primary outcome refers to measures of child neurobehavioral and neurophysiological functions. Neurobehavioral assessment includes cognitive, motor and behavioral measurement. Neurophysiological assessment refers to electroencephalogram/event-related potential examination and cognition/motor dual tasks that will be used to investigate the neurological pathways underlying the effective intervention. Secondary outcomes refer to child growth and health, and the quality of parenting measures.
详细描述
Preterm children present more cognitive impairments, psychological and behavioral problems, motor and coordination impairments than their term counterparts. These impairments may cause the difficulties of learning and adaptation at the school age when facing multiple and complicate environmental stimulations in preterm children. Accumulating data on early intervention for preterm infants in Eastern and Western countries have demonstrated short- to medium-term benefits on enhancing child neurodevelopment outcomes. However, rare studies have examined the effectiveness of early intervention for preterm infants and its underlying neural mechanism. To meet the contemporary concept of family centered care, we have developed a family-centered intervention program (FCIP) for preterm infants with very low birth weight (VLBW, birth weight <1,500 g) in Taiwan and have found short-term developmental benefit with respect to a usual care program (UCP) via a multi-centered, randomized controlled trial. Therefore, this three-year project is aimed to continuously follow-up the effectiveness of FCIP on child and parent outcomes in VLBW preterm infants at school age. A total of 275 VLBW preterm children (269 participants and 6 pilots) who had participated in our previous randomized controlled study and 45 term children will be assessed growth, health, neurobehavioral functions (cognition, language, motor and behaviors), electroencephalography and event-related potentials (in the resting state, cognitive inhibitory control and working memory procedures) and cognition/motor dual tasks at 7 years of age. Parents will be assessed for stress using the Parenting Stress Index/Long Form and quality of life with the World Health Organization Quality of Life- Brief Taiwan Version. The effect of early intervention for preterm children from the neonatal period to school age will provide important information to help medical professionals and public policy makers design effective intervention for Taiwanese preterm children. The continuous neurophysiological and neurobehavioral data are crucial for understanding the neurophysiological mechanisms underlying neurobehavioral changes following intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •birth body weight < 1500 grams
- •gestational age < 37 weeks
- •parents of Taiwan nationality, married or together at delivery, and northern family residing in greater Taipei and southern family residing in greater Tainan, Kaohsiung, or Chiayi
- •Inclusion Criteria for Term infants:
- •birth body weight > 2000 grams
- •gestational age > 37 weeks
- •parents of Taiwan nationality
排除标准
- •severe neonatal and perinatal diseases (e.g., seizures, hydrocephalus, meningitis, grade III-IV IVH and grade II NEC)
- •congenital or chromosome abnormality
- •mother < 18 years, with mental retardation or history of maternal substance abuse at any time (smoking, alcohol and drug)
- •Terminated Criteria for Preterm infants:
- •diagnosis of brain injury (e.g., PVL, stage IV ROP or greater)
- •severe cardiopulmonary disease requiring invasive or non-invasive ventilator use at hospital discharge
- •hospital discharge beyond 44 weeks' post-menstrual age.
结局指标
主要结局
Child: Neurodevelopment- The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition
时间窗: 2 years
The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (WPPSIR-IV) measures cognitive development of children aged from 6 years to 16 years and 11 months old. The test structure of WPPSIR-IV includes 14 subscales and several levels of interpretation: verbal comprehension index, perceptual reasoning index, working memory index, processing speed index and full scale intelligence quotient. The scaled score of each subscale ranges from 1 to 19. The total scaled score is the sum of the subscale scores ranging from 10 to 190. The full scale intelligence quotient will be converted from the total scaled score with a higher value indicating a better performance.
次要结局
- Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition(2 years)
- Child: Growth - weight(up to 2 years)
- Child: Growth - head circumference(up to 2 years)
- Child: Electroencephalogram (EEG)(2 years)
- Child: Event-related potential (ERP)(2 years)
- Parent function-quality of Life(2 years)
- Child: Growth - height(up to 2 years)
- Child: Past medical history(up to 2 years)
- Child: Academic performance(up to 2 years)
- Child: Behavior - Child Behavior Check List/ 4-18(2 years)
- Parent function-pressure(2 years)
- Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV(Time Frame: 1 year)