Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns

Study Overview
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Brief Summary
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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.

Official Title
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Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk

Conditions
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Premature

Intervention / Treatment
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* Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHA
* Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TG-DHA<br>TG-DHA: lactating mothers and their newborn with mothers supplemented with Triglyceride enriched in docosahexaenoic acid | Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHA<br>* 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)<br>* Other names: TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890;|
| No Intervention: Control<br>Control: lactating mothers and their newborn with no supplementation given to the mother | |
| Experimental: GPL-DHA<br>GPL-DHA: lactating mothers and their newborn with mothers supplemented with Glycerophospholipid enriched in docosahexaenoic acid | Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHA<br>* 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)<br>* Other names: GPL-DHA from Application Santé des Lipides BioParc Vichy Hauterive France: dry yolk egg powder containing glycerophospholipids enriched in DHA code AA 22/12/11;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To improve PUFA status in premature newborns |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Newborns, Human Milk, DHA, Mother-child