Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 277
- 试验地点
- 1
- 主要终点
- Infant behavior and development
研究概览
简要总结
The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA.
详细描述
Iron-deficiency anemia (IDA) is associated with alterations in infant behavior and development that may not correct with iron therapy. The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA. IDA and non-anemic infants were randomly assigned to a year of intervention or surveillance only. Infants were enrolled and began study participation at 6 or 12 months. All infants were treated with oral iron and visited weekly to record iron intake, feeding, and health (surveillance). For infants randomized to intervention, the weekly home visit included an hour-long program fostering child development by supporting the mother-infant relationship. Psychologists, unaware of iron status or intervention assignment, assessed cognitive, motor, and social-emotional development (Bayley Scales) at the beginning, midpoint, and end of the year.
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
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birth weight >= 3.0kg
- •singleton full-term birth
- •routine vaginal delivery
- •no major congenital anomalies
- •no major perinatal complications
- •no photo therapy
- •no hospitalization for longer than 5 days
- •no chronic illness
- •no iron therapy
- •from 1991-94, infants on >= 250 ml/day cow milk or formula
- •from 1994-96, infants could be on < 250 ml/day cow milk or formula
- •infants identified as anemic at 6 or 12 months and randomly selected nonanemic infants at 6 and 12 months
排除标准
- •residence outside 4 contiguous working-class communities on outskirts of Santiago, Chile
- •another infant <12 months in household
- •infant in child care
- •illiterate or psychotic caregiver or no stable caregiver available to accompany the child for appointments.
- •until mid-1994, "exclusive" breastfeeding, defined as >250 mL/d cow milk or formula
结局指标
主要结局
Infant behavior and development
时间窗: 6, 12, and 18 months; or 12, 18, and 24 months
次要结局
- Iron-deficiency anemia(6, 12, and 18 months; or 12, 18 and 24 months)