Randomized, Controlled Study of Iron Supplementation of Infants With Birth Weights 2000-2500 g
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Neurological developement
研究概览
简要总结
Iron is essential for brain development and there is a well established association between iron deficiency in infants and poor neurological development. In Sweden, about 5% of newborns have low birth weight (< 2500 g). Due to small iron stores at birth and rapid postnatal growth, they have increased risk of iron deficiency and it is therefore important to prevent iron deficiency in this population. However, excessive iron supplementation can have adverse effects in infants such as growth impairment. In a randomized, controlled trial, we are investigating the effects of 0, 1 or 2 mg/kg/d of iron on brain myelination, cognitive development and growth in low birth weight infants.
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
- 39 Days 至 45 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Marginally low birth weight (2000-2500 g)
- •Healthy at inclusion(6 weeks of age)
- •No previous blood transfusion
- •No previous iron supplementation
排除标准
- •Anemia at inclusion
研究组 & 干预措施
1
Placebo
干预措施: Iron (Drug)
3
2 mg/kg/day from age 6 weeks to 6 months
干预措施: Iron (Drug)
2
1 mg/kg/day from age 6 weeks to 6 months
干预措施: Iron (Drug)
结局指标
主要结局
Neurological developement
时间窗: 6 months, 3 years and 7 years
6 mo: Auditory brain stem response (central conduction time) 3 y: CBCL - Parental questionnaire assessing behavioral problems and WIPPSI - test of cognitive functions 7 y: SDQ, 5-15 and CBCL - Parental questionnaires assessing behavioral problems, TeAch - test of behavioral problems and WISC - test of cognitive functions.
次要结局
- Growth, Iron status, and Morbidity(3 years and 7 years)
- Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc)(6 months)