Analysis of Lipids in Human Milk at Different Gestational Ages

Study Overview
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Brief Summary
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Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and proteins. The study of lipidomic is of particular interest because the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. The study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk.

Detailed Description
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Mother's milk is the best food for the newborn as it is the only one capable of providing species-specific nutrition, guaranteeing everything necessary for the growth and maturation of a child. Mother's milk has the property of satisfying metabolic needs by changes in the composition of nutrients, which are different at each stage of life. Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, such as vitamins, macronutrients, carbohydrates and proteins. The metabolomic study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk. This is particularly important in a Neonatal Intensive Care Unit, where it is essential to ensure timely adequate enteral nutrition. This is possible if a bank of donated human milk is available. The study of lipidomics is of particular interest, as the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. Therefore, the benefit deriving from an adequate dietary intake in a constantly evolving organism such as that of a newborn is extremely important.

Official Title
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Essential Long-chain Polyunsaturated Fatty Acids Quantitation in Breast Milk Samples at Different Gestational Ages

Conditions
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Breast Milk Collection

Intervention / Treatment
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* Other: Breastfeeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mothers who have given birth in hospital at any gestational age Written informed consent BMI 18.50-24.99 Kg/m2 Varied and balanced maternal diet without restrictions Weight gain during pregnancy up to 12kg Exclusion Criteria: Food intolerance Celiac disease Vegan or vegetarian diet Diet with the exclusion of milk and derivatives Diagnosis of metabolic diseases Taking medicines during pregnancy Withdrawal of informed consent
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women < 32 weeks of gestational age<br>Women that delivered before 32 weeks of gestational age | Other: Breastfeeding<br>* Mothers will breastfeed their newborns<br>|
| Women between 32 and 36,6 weeks of gestational age<br>Women that delivered between 32 and 36,6 weeks of gestational age | Other: Breastfeeding<br>* Mothers will breastfeed their newborns<br>|
| Women > 37 weeks of gestational age<br>Women that delivered after 37 weeks of gestational age | Other: Breastfeeding<br>* Mothers will breastfeed their newborns<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of α-Linoleic acid (µg/mL) in human milk | 7 days after delivery | 
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk | 7 days after delivery | 
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk | 7 days after delivery | 
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of Arachidonic acid (µg/mL) in human milk | 7 days after delivery | 
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of Linoleic acid (µg/mL) in human milk | 7 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of α-Linoleic acid (µg/mL) in human milk | 1 month after delivery | 
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk | 1 month after delivery | 
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk | 1 month after delivery | 
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of Arachidonic acid (µg/mL) in human milk | 1 month after delivery | 
| Quantification of essential long-chain polyunsaturated fatty acids in human milk | To assess the concentrations of Linoleic acid (µg/mL) in human milk | 1 month after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newborn, breast milk, fatty acid, gestational age