Iron Metabolism in Small Pre Term Newborns
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of iron status in preterm infants and identify which preterm infants are at risk for iron deficiency or iron overload.
研究概览
简要总结
Iron is an essential micronutrient that plays an important role in cellular functions of all microorganisms. Both iron deficiency and iron excess during the early weeks of life can have severe effects on neurodevelopment that may persist into adulthood and may not be corrected by restoration of normal iron levels.
Iron overload remains a significant concern in preterm infants because they have low levels of iron-binding proteins and immature antioxidant systems.
The aim of the study is to evaluate if iron supplementation is required/necessary in VLBW Very Low Birth Weight (less than 1500 grams) and to assess the efficacy and safety of the iron supplementation practice for VLBW preterm infants as implemented in the Neonatal Intensive Care Unit (NICU) at the Ha'Emek Medical Center, Afula, Israel.
详细描述
Primary objectives
- The aim of the study is to investigate the presence and level of Cryptic LPI in pre term infants plasma before and during enteral iron supplementation.
- To assess the iron status in preterm infants and correlated them with clinical parameters: the blood transfusions given and the amount of blood obtained for routine laboratory analysis, and amount of daily iron intake through diet (human milk or formula)
- To identify which preterm infants are at risk for iron deficiency or iron overload.
- To investigate laboratory tests, Hepcidin and CHr, for the assessment of iron metabolism in preterm infants.
Secondary objectives To review the current guidelines in use for monitoring iron status and prevention of iron deficiency in VLWP.
To implement future new guidelines for monitoring iron therapy and iron supplementation in pre terms infants if the results suggest changes in the current policy.
Treatment guidelines:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very Low Birth Weight and / or borne at 30 weeks or less of gestational age that are scheduled to receive enteral iron supplementation as part of the standard protocol currently used by the Neonatal Intensive Care Unit.
- •Birth weight will be not an inclusion or exclusion criteria for preterms born at 30 weeks or less.
排除标准
- •Major physical anomalies,
- •renal or cardiac diseases,
- •newborns that underwent major surgery during the study period,
- •acute or chronic fetal blood loss,
- •hemolytic anemia,
- •refusal to receive parental consent.
研究组 & 干预措施
Iron suplementation
Iron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal
干预措施: Iron preparation (Drug)
结局指标
主要结局
Assessment of iron status in preterm infants and identify which preterm infants are at risk for iron deficiency or iron overload.
时间窗: One year
Assessment of the iron status in preterm infants and correlated them with clinical parameters: the blood transfusions given and the amount of blood obtained for routine laboratory analysis, and amount of daily iron intake through diet (human milk or formula)and identify which preterm infants are at risk for iron deficiency or iron overload.
次要结局
未报告次要终点
研究者
Dr Koren Ariel
Head of Pediatric Dpt B and Pediatric Hematology Unit
HaEmek Medical Center, Israel