Effect of Mother DHA Supplementation on Premature Newborn.
Condition: Oxidative Stress
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): DHA; control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): We will establish two groups of premature newborn children (<34 weeks) (n=40) and one group of newborn children to term (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).; We will establish two groups of premature newborn children (<34 weeks) (n=40) and one group of newborn children to term (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 during the lactation (minimum period of 3 months).
Other intervention name(s): Docosahexaenoic acid; Follow on capsules without probiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: neonates, DHA