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临床试验/NCT00683527
NCT00683527已完成不适用

New Versus Standard Enteral Iron Supplementation Regime in Very Low Birth Weight Infants - A Randomized Controlled Trial

All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Serum ferritin

研究概览

简要总结

To examine if early iron supplementation (starting oral iron at 14 days of life) would improve the nutritional iron status(measured by serum ferritin) of very low birth weight infants at postnatal age of 60 days, when compared to the standard regime of starting iron at 2 months of life.

详细描述

Smaller the preterm infants at birth, more susceptible they are to iron deficiency due to low body iron stores. Despite having low iron stores, very low birth weight (VLBW) infants are not usually started on iron supplementation till they reach a postnatal age of 6 to 8 weeks. Such delayed supplementation can lead to rapid depletion of iron stores when erythropoiesis becomes active (by 8 weeks of life).

Depletion of iron stores is the first step in the continuum of changes that occur in iron deficiency. Iron deficiency induces biochemical defects (such as impaired synthesis of DNA and collagen) even before any features of microcytic, hypochromic anemia become evident. The rapidly maturing preterm brain is especially vulnerable to the effects of iron deficiency; poor school-age performance has been reported among children who had low iron stores in their neonatal period.

Early iron supplementation i.e. starting iron once the infant reaches full enteral feeds could potentially improve the iron stores and prevent its depletion. Surprisingly, few studies are available till date to support (or refute!) this view. The current study was designed to test the hypothesis whether early iron supplementation would increase the nutritional iron status (as measured by serum ferritin) at 60 days of life when compared to the existing regime of starting iron at the age 2 months.

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
None

入排标准

年龄范围
14 Days 至 60 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants who have reached at least 100 ml/kg/day of oral feeds by day 14 of life

排除标准

  • Major congenital anomalies
  • Rh hemolytic disease
  • Twin-to-twin transfusion syndrome
  • Refusal to give consent

研究组 & 干预措施

1

Experimental

Starting oral iron at day 14 of life (Early Iron group)

干预措施: Elemental iron (Drug)

结局指标

主要结局

Serum ferritin

时间窗: 60 days postnatal age

次要结局

  • Composite outcome of neonatal morbidities that include chronic lung disease [CLD], necrotizing enterocolitis [NEC-any stage], periventricular leucomalacia [PVL], and retinopathy of prematurity [ROP] requiring treatment(Till the end of study period (2 months))
  • Hematologic and anthropometric parameters(at 60 days of age)
  • Requirement of blood transfusion(till the end of study period)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other

研究点 (1)

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