跳至主要内容
临床试验/NCT05989009
NCT05989009招募中不适用

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

Ospedale Buon Consiglio Fatebenefratelli2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
2
主要终点
Quantification of essential long-chain polyunsaturated fatty acids in human milk

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 7 days after delivery

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

次要结局

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk(1 month after delivery)

研究者

发起方
Ospedale Buon Consiglio Fatebenefratelli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe De Bernardo

Head of Department of Woman and Child

Ospedale Buon Consiglio Fatebenefratelli

研究点 (2)

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