Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hematocrit (Hct)
研究概览
简要总结
The purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •cyanotic heart disease
- •bowel resection prior to enrollment
研究组 & 干预措施
iron supplementation
2 mg/kg/day of elemental iron as a multivitamin with iron solution
干预措施: Iron Supplement (Drug)
control
multivitamin solution without iron
干预措施: control (Drug)
结局指标
主要结局
Hematocrit (Hct)
时间窗: 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.
次要结局
- Transfusions(enrollment to 36 weeks postmenstrual age (PMA))
研究者
Kathleen Kennedy
Professor - Pediatrics, Neonatology
The University of Texas Health Science Center, Houston