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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00006-51 | Registry Identifier | IDRCB |
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difficulties of recruitement
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG-DHA | Active Comparator | TG-DHA: lactating mothers and their newborn with mothers supplemented with Triglyceride enriched in docosahexaenoic acid |
|
| Control | No Intervention | Control: lactating mothers and their newborn with no supplementation given to the mother | |
| GPL-DHA | Experimental | GPL-DHA: lactating mothers and their newborn with mothers supplemented with Glycerophospholipid enriched in docosahexaenoic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplementation of lactating mothers who has delivered prematurely with DHA | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| To improve PUFA status in premature newborns | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| PUFA in human milk (HM) and mothers | 6 months | |
| Impact on HM bioactives | 6 months | |
| Change in inflammation and oxydative stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Véronique Millet, MD, PhD | Institut National de la Santé Et de la Recherche Médicale, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Médecine néonatale, Hôpital de la Conception | Marseille | 13385 | France |
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|
| Supplementation of lactating mothers who has delivered prematurely with DHA | Dietary Supplement | Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by GPL-DHA from ASL (10 g per day) (two soft capsules per day) |
|
|
| 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 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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