Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
研究概览
简要总结
In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted postmenstrual age (or at discharge if sooner)?
详细描述
Fortified mother's milk or fortified formula is routine practice in neonatal units and is not an intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birth weight <1500 grams
- •Tolerating iron fortified preterm formula or fortified human milk at 120cc/kg/day by 8 weeks of age
- •</= 32 weeks adjusted post-menstrual age at the time of enrollment
排除标准
- •Cyanotic heart disease
- •Bowel resection prior to enrollment
研究组 & 干预措施
multivitamin without iron
daily oral multivitamin without iron
干预措施: multivitamin (Dietary Supplement)
multivitamin with iron
daily oral multivitamin providing 2mg/kg of iron
干预措施: Iron Supplement (Dietary Supplement)
结局指标
主要结局
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
时间窗: at 36 weeks adjusted postmenstrual age
For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome.
次要结局
- Number of Participants Who Received Red Cell Transfusions During Intervention Period(from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner)