A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 6
- 主要终点
- Child: neurodevelopment functions (cognition, language and motor)
研究概览
简要总结
Four hypotheses will be tested in this study:
- The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period.
- The intervention group shows greater changes in early neurophysiological brain functions and transactions within the family that lead to better neurodevelopmental outcomes than the control group.
- Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants.
- Very low birth weight preterm infants carrying more genetic plasticity in the dopamine-related genes may benefit more from the interventions than those carrying less genetic plasticity.
详细描述
A total of 275 VLBW preterm infants (269 participants and 6 pilots) were recruited at three medical centers in northern and southern Taiwan and were randomly assigned to the FCIP or UCP group. Outcome assessments included primary (neurobehavioral development) and secondary measures (neurophysiological performance, parents' stress and transactions within the family). The neurophysiological and transactions data were examined for whether they mediate intervention effects on child development. In addition, these infants 219 VLBW preterm infants and 118 term infants in our prior intervention studies were collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensorimotor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses. The polymorphisms of dopamine-related genes were examined for potential moderating influence on the effects of the intervention for child development.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
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
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:
- •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 functions (cognition, language and motor)
时间窗: 24 months of corrected age
Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition
次要结局
- Parental functions and change from baseline (pressure)(0, 6, 12, 18, and 24 months of corrected age)
- Transactional functions and change from baseline(6 and 12 months of corrected age)
- Child: neurophysiological functions and change from baseline(1 and 4 months of corrected age)
- Change of neurodevelopment functions (motor) from baseline(0 months of corrected age)
- Change of neurodevelopment functions (cognition, language and motor) from baseline(6,12, and 24 months)
- Child: Medical data(Birth to 24 months of corrected age)
- Parental adherence to Intervention(32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months)
- Child: neurodevelopment functions (behavior)(24 months of corrected age)
- Parental functions and change from baseline (Quality of Life)(0, 6, 12, 18, and 24 months of corrected age)
- Child: growth data and change from baseline(0, 1, 4, 6, 12, 18, and 24 months of corrected age)
- Child: genotyping and gene expression(0 month of corrected age)
- Transactions function: affordance(18 months of corrected age)