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Analysis of Lipids in Human Milk At Different Gestational Ages

Essential Long-chain Polyunsaturated Fatty Acids Quantitation in Breast Milk Samples At Different Gestational Ages

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05989009
Enrollment
66
Registered
2023-08-14
Start date
2022-03-01
Completion date
2023-10-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Milk Collection

Keywords

newborn, breast milk, fatty acid, gestational age

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.

Interventions

OTHERBreastfeeding

Mothers will breastfeed their newborns

Sponsors

University of Salerno
CollaboratorOTHER
Ospedale Buon Consiglio Fatebenefratelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quantification of essential long-chain polyunsaturated fatty acids in human milk7 days after deliveryTo assess the concentrations of α-Linoleic acid (µg/mL) in human milk

Secondary

MeasureTime frameDescription
Quantification of essential long-chain polyunsaturated fatty acids in human milk1 month after deliveryTo assess the concentrations of α-Linoleic acid (µg/mL) in human milk

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026