NCT01444261已完成4 期
Prevention of Iron Deficiency in Breastfed Infants
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2010年12月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 2
- 主要终点
- Iron deficiency anemia will be prevented in all infants before 5.5 mo of age
研究概览
简要总结
With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.
详细描述
Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.
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
- None
入排标准
- 年龄范围
- 4 Weeks 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants
- •gestational age 37-42 weeks
- •birth weight > 2500 g
- •exclusively breastfed at 28 d of age
- •intend to breast feed until 9 mo of age
排除标准
- •supplemental formula before 4 mo of age
结局指标
主要结局
Iron deficiency anemia will be prevented in all infants before 5.5 mo of age
时间窗: 5.5 mo
Iron deficiency anemia will be defined as plasma ferritin less than 10 ug/L and hemoglobin less than 105 g/L. The expected outcome is there will be no infants with iron deficiency anemia before 5.5 mo of age.
次要结局
- Determine the number of infants with iron deficiency between 5.5 and 9 mo of age(9 mo)
研究者
Ekhard Ziegler
Professor
University of Iowa
研究点 (2)
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