Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- To improve PUFA status in premature newborns
研究概览
简要总结
Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Childbirth between 34 and 35 GA
- •Breast-feeding
- •Caucasian
- •Affiliation to social security
- •Obtained consent from mother, and parents for the child
- •Mother with balanced diet
- •No allergy to eggs
- •Single pregnancy
排除标准
- •Allergy to egg
- •Unbalanced diet
- •Known digestive disease
- •Counter-indication with breast-feeding
- •Cigarettes (more than 5 per day)
- •Alcoholism (daily consumption of alcohol)
- •Multiple pregnancy
结局指标
主要结局
To improve PUFA status in premature newborns
时间窗: 30 days
次要结局
- PUFA in human milk (HM) and mothers(6 months)
- Impact on HM bioactives(6 months)
- Change in inflammation and oxydative stress(6 months)
- Genes expression in newborns(6 months)
- Link between mothers genetics and HM DHA level(6 months)
- Newborn survey at 6 month-old(6 months)