Nutrition, Growth and Development Among Very Preterm Infants
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Reduction in discharge rate of small-for-gestational age very low birth weight infants
研究概览
简要总结
The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and arachidonic acid on growth, brain maturation and cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight below 1,500 grams
- •Written consent to participate from the parents
排除标准
- •Congenital malformations
- •Clinical syndromes known to affect growth and development
- •Critical illness and short life expectancy
- •If participants refuse to participate
研究组 & 干预措施
Control
Participants in this group will receive nutrition from birth and during the hospital stay until discharge according to the routines of the participating institutions.
干预措施: Nutrition (Dietary Supplement)
Intervention
The participants in this group will receive increased supply of energy, protein, vitamin A, docosahexaenoic acid, and arachidonic acid from birth and during the hospital stay until discharge.
干预措施: Nutrition (Dietary Supplement)
结局指标
主要结局
Reduction in discharge rate of small-for-gestational age very low birth weight infants
时间窗: 6 months corrected age
The primary endpoint is to reduce the discharge rate of very low birth weight infants that are small-for-gestational age, from 60 to 40%.
次要结局
- Evaluation of brain function and growth of infant(6 months corrected age)
研究者
Per Ole Iversen, MD
Professor
University of Oslo