Analysis of Lipids in Human Milk at Different Gestational Ages

Sponsor
Ospedale Buon Consiglio Fatebenefratelli (Other)
Overall Status
Recruiting
CT.gov ID
NCT05989009
Collaborator
University of Salerno (Other)
66
2
19
33
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
66 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Essential Long-chain Polyunsaturated Fatty Acids Quantitation in Breast Milk Samples at Different Gestational Ages
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Quantification of essential long-chain polyunsaturated fatty acids in human milk [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 [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 [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 [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 [7 days after delivery]

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

Secondary Outcome Measures

  1. Quantification of essential long-chain polyunsaturated fatty acids in human milk [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 [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 [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 [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 [1 month after delivery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Pharmacy, University of Salerno Salerno Naples Italy 84084
2 Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital Napoli Italy 80123

Sponsors and Collaborators

  • Ospedale Buon Consiglio Fatebenefratelli
  • University of Salerno

Investigators

  • Principal Investigator: Giuseppe De Bernardo, MD, Ospedale Buon Consiglio Fatebenefratelli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Giuseppe De Bernardo, Head of Department of Woman and Child, Ospedale Buon Consiglio Fatebenefratelli
ClinicalTrials.gov Identifier:
NCT05989009
Other Study ID Numbers:
  • 1669
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Giuseppe De Bernardo, Head of Department of Woman and Child, Ospedale Buon Consiglio Fatebenefratelli

Study Results

No Results Posted as of Aug 15, 2023