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Analysis of Lipids in Human Milk At Different Gestational Ages

O

Ospedale Buon Consiglio Fatebenefratelli

Status

Completed

Conditions

Breast Milk Collection

Treatments

Other: Breastfeeding

Study type

Observational

Funder types

Other

Identifiers

NCT05989009
1669/CE Lazio 1

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

66 participants in 3 patient groups

Women < 32 weeks of gestational age
Description:
Women that delivered before 32 weeks of gestational age
Treatment:
Other: Breastfeeding
Women between 32 and 36,6 weeks of gestational age
Description:
Women that delivered between 32 and 36,6 weeks of gestational age
Treatment:
Other: Breastfeeding
Women > 37 weeks of gestational age
Description:
Women that delivered after 37 weeks of gestational age
Treatment:
Other: Breastfeeding

Trial contacts and locations

2

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Central trial contact

Giuseppe De Bernardo, MD

Data sourced from clinicaltrials.gov

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