Analysis of Lipids in Human Milk at Different Gestational Ages
- Conditions
- Breast Milk Collection
- Interventions
- Other: Breastfeeding
- Registration Number
- NCT05989009
- Lead Sponsor
- Ospedale Buon Consiglio Fatebenefratelli
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women between 32 and 36,6 weeks of gestational age Breastfeeding Women that delivered between 32 and 36,6 weeks of gestational age Women > 37 weeks of gestational age Breastfeeding Women that delivered after 37 weeks of gestational age Women < 32 weeks of gestational age Breastfeeding Women that delivered before 32 weeks of gestational age
- Primary Outcome Measures
Name Time Method Quantification of essential long-chain polyunsaturated fatty acids in human milk 7 days after delivery To assess the concentrations of Linoleic acid (µg/mL) in human milk
- Secondary Outcome Measures
Name Time Method Quantification of essential long-chain polyunsaturated fatty acids in human milk 1 month after delivery To assess the concentrations of Linoleic acid (µg/mL) in human milk
Trial Locations
- Locations (2)
Department of Pharmacy, University of Salerno
🇮🇹Salerno, Naples, Italy
Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital
🇮🇹Napoli, Italy