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临床试验/NCT01940640
NCT01940640已完成2 期

Multidisciplinary Study of the Effect of the Mother suplementación During the Lactation With High Doses of DHA on Diverse Aspects Related to the Development of the Premature Newborn in the First Year of Life.

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
2
主要终点
blood and milk samples

研究概览

简要总结

To date, the investigations in the field of the supplementation with DHA in premature babies have been focused on the study of neuronal and visual development, giving place to contradictory and ambiguous results, because they did not consider in many cases important aspects of this supplementation, such as the mother´s diet, dose, duration, etc., and precise studies have not been performed in the field of the oxidative damage, inflammation and bone development in this population.

Hypothesis: If the composition of the mother´s milk is modified on the basis of her diet, a mother supplementation with high doses of DHA will increase proportionally the levels of this fatty acid in her milk, fact that will allows the premature newborn child receive a major dose of this fatty acid, and therefore this way, we will manage to improve the neuronal and visual development and to take part on the inflammatory process, oxidative damage and its evolution, together with the development or bone mass increase in the premature baby.

Aims: Overall we aim to evaluate in a multidisciplinary way the effect of a mother supplementation during the lactation with high doses of DHA on the development and wellness of the premature newborn children. We try to deepen into the effect on the neuronal and visual development and to study, for the first time, the effect on the oxidative damage, pro- and antiinflammatory citoquines activity and bone metabolism in this group of newborn babies.

详细描述

Experimental design: We will establish two groups of premature newborn children (<34 weeks) (n=40). The mothers of one of the groups of premature newborn children will receive an oral supplementation by means of capsules with high dose of DHA (900 mg/day) during the lactation (minimum period of 3 months). In addition, all the groups will be underwent to a nutritional surveillance (a follow-up of 48 hours and a questionnaire of frequency of consumption) and will be given nutritionally-balanced diets, insisting especially in the suitable consumption of fish (4 portions/week). Blood samples will be obtained in all the groups at the birth moment, at the week 40 of gestational age corrected in the groups of premature babies and at the end of the lactation in all the groups (minimum 3 months).We will obtain samples of mother´s milk (colostrum, transition and mature milk). In these samples we will study bone turnover biomarkers, pro - and anti-inflammatory citoquines and markers of aggression oxidative damage. In addition, we will perform psychomotor and visual development tests in the newborn children.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
1 Hour 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm neonate, gestational age 30-34, PAEG (>P10, <P95), no pathologies.

排除标准

  • Lactose intolerance, systemic illness, multiple gestation, cromosomopathies, antibacterial therapy.

结局指标

主要结局

blood and milk samples

时间窗: at delivery

Assessment of oxidative stress

次要结局

  • Blood(at delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julio J. Ochoa

Julio J. Ochoa

Universidad de Granada

研究点 (2)

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