Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- To improve PUFA status in premature newborns
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
To improve PUFA status in premature newborns
Time Frame: 30 days
Secondary Outcomes
- 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)