B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS
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
- 是
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)
