Early Family-Based Intervention for Developmental Enforcement of Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Bayley Scales of Infant and Toddler Development III, mental developmental index
研究概览
简要总结
This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than control group of VLBW infants, study population includes term infants to compare neurodevelopmental outcome.
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
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •preterm infants < 32 weeks of gestation or 1,500 gm of birth weight
- •normal term infants
排除标准
- •major congenital anomaly
- •neuromuscular disease
- •chromosomal anomaly
- •triplets or more multiplets
研究组 & 干预措施
VLBW infant intervention
Combined home visiting and group intervention for very low birth weight infant
干预措施: Combined home visiting and group intervention (Behavioral)
VLBW infant control
very low birth weight infant without intervention
干预措施: No intervention (Other)
Term infant control
term infant without intervention
干预措施: No intervention (Other)
结局指标
主要结局
Bayley Scales of Infant and Toddler Development III, mental developmental index
时间窗: Corrected age 10 months
次要结局
- Bayley Scales of Infant and Toddler Development III, psychomotor developmental index(Corrected age 10 month)
- Maternal attachment(Corrected age 2 month & 6 month)
- Temperament scale(Corrected age 8 month)
- Wechsler Intelligence Scale(8 years of age)
- CES-D-depression screening tool(Corrected age 2 month & 6 month)
- Conners ADHD/DSM-IV Scales(8 years of age)
研究者
Ee-Kyung Kim
Clinical associate professor
Seoul National University Hospital