Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants
Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants
研究概览
详细说明
Objective was to determine if iron supplementation of 2 mg/kg per day, in addition to routine iron-fortified formula or mother's milk, increased the hematocrit (Hct) at 36 weeks' postmenstrual age (PMA).
All infants have a decline in hemoglobin(Hgb) after birth because of increasing PaO2 and Hgb saturation after birth. In very low birth weight (VLBW) infants (birth weight ,1500 g), the nadir at 1 to 3 months after birth is lower than in term infants because of (1) greater phlebotomy losses for blood tests, (2) shortened red blood cell survival, and (3)rapid growth.
VLBW infants may be at increased risk of developing iron deficiency anemia because of (1) low iron stores at birth, (2) rapid depletion of iron stores owing to phlebotomy losses, and (3) inability to regulate iron absorption by the gastrointestinal tract.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77030
- Children's Memorial Hermann Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- birth weight: < 1500 grams
- Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age
- ≤32 weeks adjusted post-menstrual age at the time of enrollment
Exclusion Criteria:
- cyanotic heart disease
- bowel resection prior to enrollment
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：iron supplementation
2 mg/kg/day of elemental iron as a multivitamin with iron solution
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2 mg/kg/day elemental iron as multivitamin with iron solution
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假比较器：control
multivitamin solution without iron
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multivitamin solution without iron
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hematocrit (Hct)
大体时间：36 weeks postmenstrual age (PMA)
|
For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used.
For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available.
For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used.
For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing.
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36 weeks postmenstrual age (PMA)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Transfusions
大体时间：enrollment to 36 weeks postmenstrual age (PMA)
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# of transfusions infants required after enrollment.
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enrollment to 36 weeks postmenstrual age (PMA)
|
合作者和调查者
调查人员
- 首席研究员：Kennedy Kathleen, MD、The University of Texas Health Science Center, Houston
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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