Clinical trial NCT05989009: Analysis of Lipids in Human Milk At Different Gestational Ages
Official title: Essential Long-chain Polyunsaturated Fatty Acids Quantitation in Breast Milk Samples At Different Gestational Ages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Milk Collection
Keywords: newborn
breast milk
fatty acid
gestational age
Lead sponsor: Ospedale Buon Consiglio Fatebenefratelli
Sponsor class: OTHER
Collaborators: name: University of Salerno
First posted: 2023-08-14
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: They were enrolled mothers that delivered at Buon Consiglio Fatebenefratelli Hospital, Napoli

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 7 days after delivery
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 7 days after delivery
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 7 days after delivery
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 7 days after delivery
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 7 days after delivery
Secondary outcomes:
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 1 month after delivery
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 1 month after delivery
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 1 month after delivery
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 1 month after delivery
measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
timeFrame: 1 month after delivery
Other outcomes:
Locations:
city: Salerno
country: Italy
facility: Department of Pharmacy, University of Salerno
state: Naples
city: Napoli
country: Italy
facility: Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital
Study officials:
affiliation: Ospedale Buon Consiglio Fatebenefratelli
name: Giuseppe De Bernardo, MD
role: PRINCIPAL_INVESTIGATOR
References: