Premature
Conditions
Keywords
Premature Newborns, Human Milk, DHA, Mother-child
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.
Interventions
DIETARY_SUPPLEMENTSupplementation of lactating mothers who has delivered prematurely with DHA
Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by TG-DHA from Decola (products from Martek) (two soft capsules per day)
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 40 Years
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 * Diabetes * Known digestive disease * Counter-indication with breast-feeding * Cigarettes (more than 5 per day) * Alcoholism (daily consumption of alcohol) * Multiple pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To improve PUFA status in premature newborns | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Impact on HM bioactives | 6 months |
| Change in inflammation and oxydative stress | 6 months |
| PUFA in human milk (HM) and mothers | 6 months |
| Link between mothers genetics and HM DHA level | 6 months |
| Newborn survey at 6 month-old | 6 months |
| Genes expression in newborns | 6 months |
Countries
France
Outcome results
None listed