Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- plasma phospholipid fatty acid composition
研究概览
简要总结
The investigators examined the effect of different levels of docosahexaenoic aicd (a long chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid into their corresponding long chain polyunsaturated fatty acids was studied.
Preterm infants were randomized in a double-blind fashion to one of three formulas containing different amounts of docosahexaenoic acid during the first two weeks of postnatal life. A control group received human milk. Blood samples were collected at study entry and 14 and 28 days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were applied orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56 weeks visually evoked potentials were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm birth
- •birth weight between 1000 and 2200 g
- •more than 80 % of energy intake from infant formula or human milk at enrollment
排除标准
- •apparent genetic, gastrointestinal or metabolic disorders
- •artificial ventilation or oxygen supply > 30% at the time of enrollment
- •administration of parenteral fat emulsion (> 1 g/kg/day for more than seven days) before or after study entry
研究组 & 干预措施
medium docosahexaenoic acid formula
干预措施: medium docosahexaenoic acid formula (Dietary Supplement)
high docosahexaenoic acid formula
干预措施: high docosahexaenoic acid formula (Dietary Supplement)
human milk
干预措施: breast milk (Dietary Supplement)
low docosahexaenoic acid formula
干预措施: low docosahexaenoic acid formula (Dietary Supplement)
结局指标
主要结局
plasma phospholipid fatty acid composition
时间窗: 28 days after intervention start
visually evoked potentials
时间窗: 48 weeks and 56 weeks postconceptional age
次要结局
- intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids(28 days after study start)