Analysis of Lipids in Human Milk At Different Gestational Ages

NCT ID: NCT05989009

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-10-01

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.

Conditions

Breast Milk Collection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women < 32 weeks of gestational age

Women that delivered before 32 weeks of gestational age

Breastfeeding

Intervention Type: OTHER

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

Breastfeeding

Intervention Type: OTHER

Mothers will breastfeed their newborns

Women > 37 weeks of gestational age

Women that delivered after 37 weeks of gestational age

Breastfeeding

Intervention Type: OTHER

Mothers will breastfeed their newborns

Interventions

Breastfeeding

Mothers will breastfeed their newborns

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Salerno

OTHER

Sponsor Role: collaborator

Ospedale Buon Consiglio Fatebenefratelli

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe De Bernardo

Head of Department of Woman and Child

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe De Bernardo, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Buon Consiglio Fatebenefratelli

Locations

Department of Pharmacy, University of Salerno

Salerno, Naples, Italy

Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital

Napoli, Napoli, Italy

Countries

Italy

Other Identifiers

1669/CE Lazio 1

Identifier Type: -

Identifier Source: org_study_id