Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of participants with Hematological evaluation
研究概览
简要总结
There are wide variations in iron supplementation practices in NICU.Guidelines on pediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.
详细描述
The study was approved by the ethics committee of Xinhua Hospital, and all parents gave written informed consent.
Study Design This was a randomized, controlled, double-blind, interventional trial of iron (iron sucrose) supplementation given from age of 1 day until full 2 weeks to preterm infants in NICU, who divided into three groups, control(PN without iron and EPO), Vifor and vifor and EPOE group, according to the recommended dosage of ESPEN .
Outcome Measures General information and indicators including anemia iron storage were measured. And the same time oxidative stress indicators were monitored at age of 1day and 2 weeks.
General growth parameters including the blood sugar, liver and renal function index before and after the intervention were tested.
Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were mesured before and after the intervention. The three groups were all peripheral blood.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with birth weight less than 2.5kg Have parenteral nutrition indication With written informed consent of parents or guardian
排除标准
- •Kidney and liver function abnormal have hemolytic disease have hemorrhagic disease have Serious congenital malformation have septicemia have plethora newborn use TPN less than ten days
研究组 & 干预措施
Vifor and EPO
intravenous iron and EPO
干预措施: Vifor and EPO (Drug)
control
no intravenous iron or EPO
干预措施: standard PN (Other)
Vifor
intravenous iton but no EPO
干预措施: Vifor (Drug)
结局指标
主要结局
Number of participants with Hematological evaluation
时间窗: up to 2 weeks
Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were measured before and after the intervention. The three groups were all peripheral blood.
次要结局
- Iron storage(up to 2 weeks)
研究者
Wang Hua
Ethics Committee of Kunshan First People's Hospital
Kunshan First People's Hospital Affiliated to Jiangsu University