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临床试验/NCT00457990
NCT00457990已完成不适用

Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301g - Neurocognitive Development at 5.3 Years Corrected Age

University of Ulm2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2002年4月1日最近更新:
适应症
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
204
试验地点
2
主要终点
the number of infants who fulfilled the criteria of ID at any time throughout the study.

研究概览

简要总结

Background: Iron deficiency in early childhood may impair neurodevelopment.

Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.

Method: Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry.

详细描述

Children with a birth weight of < 1301g who participated in a randomized controlled trial of early versus late enteral iron supplementation were evaluated applying a standardized neurological evaluation, the Kaufmann Assessment Battery for Children, and the Gross Motor Function Classification Scale (GMFCS) at the age of school entry.

Severe disability was defined as any of the following: any abnormal neurological examination associated with a severely impaired mobility (GMFCS>1), severe cognitive impairment (mental processing composite (MPC) <51), hearing loss requiring amplification, or blindness. The absence of disability was defined as normal neurological examination, normal mobility (GMFCS=0), and normal cognitive development (MPC>85) and the absence of any severe hearing and visual impairment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • inborn infants with a birth weight of <1301g admitted between June 1996 and June 1999

排除标准

  • major anomalies, hemolytic disease, twin-to-twin transfusion syndrome, missing parental consent

结局指标

主要结局

the number of infants who fulfilled the criteria of ID at any time throughout the study.

ferritin at 61 days of life

次要结局

  • Disability Status
  • Behavioural Problems
  • Neurological Status
  • Mental Processing Composite (Kaufmann Assessment Battery for Children)

研究者

发起方
University of Ulm
申办方类型
Other

研究点 (2)

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