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临床试验/NCT01201005
NCT01201005已完成不适用

B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Changes in biochemical status and neurodevelopment

研究概览

简要总结

Premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. During the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months infants with biochemical signs of impaired cobalamin status (i.e.: tHcy > 97.5 percentile for cobalamin treated infants, i.e.: tHcy>6.5 µM/L) will be randomised to cobalamin treatment or placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo treatment according to infant biochemical status and neurodevelopment.

Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency will normalize biochemical status and cause improved motor neurodevelopment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Birthweight < 3000 grams
  • Age 6 months (+/- 0.5 months)
  • Plasma total homocysteine > 6.5 umol/L

排除标准

  • Plasma total homocysteine < 6.5 umol/L

结局指标

主要结局

Changes in biochemical status and neurodevelopment

时间窗: 4 weeks

Bloodsamples for analysis of B vitamin status are drawn before intervention and after 4 weeks Neurological evaluation (AIMS test) of the infants is done before intervention and after 4 weeks

次要结局

  • Maternal evaluation of changes in infant behaviour/development(4 weeks)

研究者

发起方
Haukeland University Hospital
申办方类型
Other

研究点 (2)

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