NCT00684697已完成不适用
Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- mean interpeak latency Auditory Neural Myelination
研究概览
简要总结
Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Babies less than or equal to 33 weeks gestational age
排除标准
- •Infants with cranio-facial malformations
- •Torch infections
- •Infants with hearing disorders
- •Infants receiving erythropoietin
- •Infants with subnormal vitamin E levels
- •Infants with severe anemia
- •Infants who are not on full feeds
- •Infant with in-utero exposure to cocaine
研究组 & 干预措施
3
Experimental
High Iron dose
干预措施: iron (Dietary Supplement)
2
Active Comparator
intermediate iron dose
干预措施: iron (Dietary Supplement)
1
Placebo Comparator
low iron dose
干预措施: iron (Dietary Supplement)
结局指标
主要结局
mean interpeak latency Auditory Neural Myelination
时间窗: 43-45 weeks PMA
This will be measured using auditory brain stem response.
mean visual neural myelination
时间窗: 43-45 weeks PMA
Visual myelination will be evaluated by visual evoked response.
次要结局
- number of participants with executed function(3-5 years)
研究者
研究点 (1)
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