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Completed

NCT Number: NCT05989009

Analysis of Lipids in Human Milk 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pharmacy, University of Salerno, Salerno, Naples, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breastfeeding

Other

Mothers will breastfeed their newborns

Primary outcomes

  1. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 7 days after delivery

    To assess the concentrations of α-Linoleic acid (µg/mL) in human milk

  2. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 7 days after delivery

    To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk

  3. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 7 days after delivery

    To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk

  4. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 7 days after delivery

    To assess the concentrations of Arachidonic acid (µg/mL) in human milk

  5. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 7 days after delivery

    To assess the concentrations of Linoleic acid (µg/mL) in human milk

Secondary outcomes

  1. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 1 month after delivery

    To assess the concentrations of α-Linoleic acid (µg/mL) in human milk

  2. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 1 month after delivery

    To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk

  3. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 1 month after delivery

    To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk

  4. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 1 month after delivery

    To assess the concentrations of Arachidonic acid (µg/mL) in human milk

  5. Quantification of essential long-chain polyunsaturated fatty acids in human milk

    Time frame: 1 month after delivery

    To assess the concentrations of Linoleic acid (µg/mL) in human milk

Sponsors and collaborators

Lead sponsor

Ospedale Buon Consiglio Fatebenefratelli

Other

Collaborators

  • University of Salerno

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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