NCT00675337Unknown不适用
The Effect of Infant Placement at Delivery on Iron Stores in Early Infancy: A Pilot Study
Davison, James, D.O.0 个研究点目标入组 30 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- serum ferritin level at 4 months of age
研究概览
简要总结
This is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. It is possible that placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron stores during early infancy.
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
- Single (Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy pregnant women
- •37 - 42 weeks of gestation
- •vaginal delivery
- •prenatal care initiated prior to 20 weeks of gestation
排除标准
- •maternal diabetes
- •intrauterine growth restriction
- •hypertensive disorders of pregnancy
- •chronic hypertension requiring medical therapy
- •Apgar score less than 7 at 5 minutes
- •unusual bleeding prior to delivery
- •alloimmunization
- •maternal hemoglobinopathy
- •need for immediate infant resuscitation preventing adherence to protocol
结局指标
主要结局
serum ferritin level at 4 months of age
时间窗: 4 months
次要结局
- blood parameters (hemoglobin and hematocrit)(2 months and 4 months)
- serum ferritin at 2 months(2 months)
- blood parameters (hemoglobin and hematocrit) at 24 hrs of age(24 hrs.)
研究者
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