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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Milk Collection
• Intervention / Treatment: Other: Breastfeeding

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.

• Study Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: Giuseppe De Bernardo, MD; Phone Number: 3357441303; Email: pinodebtin@gmail.com

Study Locations

• Italy
  • Napoli, Italy, 80123
    • Recruiting
    • Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital
    • Contact: Giuseppe De Bernardo; Phone Number: 3357441303; Email: pinodebtin@gmail.com
    • Principal Investigator: Giuseppe De Bernardo, MD
    • Sub-Investigator: Maurizio Giordano, Dr
    • Sub-Investigator: Giuseppina Leone, MD
  • Naples
    • Salerno, Naples, Italy, 84084
      • Recruiting
      • Department of Pharmacy, University of Salerno
      • Contact: Pietro Campiglia, Prof; Email: pcampiglia@unisa.it
      • Sub-Investigator: Pietro Campiglia, Prof
      • Sub-Investigator: Giacomo Pepe, Prof
      • Sub-Investigator: Manuela Giovanna Basilicata, Dr
      • Sub-Investigator: Emanuela Salviati, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

They were enrolled mothers that delivered at Buon Consiglio Fatebenefratelli Hospital, Napoli

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women < 32 weeks of gestational age; Women that delivered before 32 weeks of gestational age	Other: Breastfeeding; Mothers will breastfeed their newborns
Women between 32 and 36,6 weeks of gestational age; Women that delivered between 32 and 36,6 weeks of gestational age	Other: Breastfeeding; Mothers will breastfeed their newborns
Women > 37 weeks of gestational age; Women that delivered after 37 weeks of gestational age	Other: Breastfeeding; Mothers will breastfeed their newborns

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ospedale Buon Consiglio Fatebenefratelli
• Collaborators: University of Salerno
• Investigators: Principal Investigator: Giuseppe De Bernardo, MD, Ospedale Buon Consiglio Fatebenefratelli

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: newborn; breast milk; fatty acid; gestational age
• Other Study ID Numbers: 1669

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No