A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Cognitive development
研究概览
简要总结
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants
Background:
Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human milk and preterm formulas contain DHA and AA, but at lower concentrations than required to approximate utero accretion rate.
Objective:
To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.
Design:
A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal centers.
Subjects and methods:
Infants with birth weight < 1.5 kg are randomized to either an intervention or a control group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for fatty acid pattern using high performance liquid chromatography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight < 1500 g
- •Born at one of 4 participating neonatal centers in Norway
排除标准
- •Cerebral haemorrhage (stage 3 or 4)
- •Major congenital malformations that are supposed to affect growth and development
- •Illness that require prolonged parenteral nutrition (>4 weeks)
结局指标
主要结局
Cognitive development
次要结局
- Growth
- Adverse events