跳至主要内容
临床试验/NCT06487286
NCT06487286招募中不适用

Levels of Visfatin/NAMPT in Human Milk.VISFAMILK

Paolo Manzoni Study Group1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月24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
30
试验地点
1
主要终点
Visfatin levels

研究概览

简要总结

Visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the weight loss of the neonate.

详细描述

The aim of the study is to analyse a retrospective cohort of well characterized mothers in their post-partum period, and to measure Visfatin levels through collection of maternal milk samples. They will be collected in three different moments after the birth (48 hours, 7 days and 30 days) and Visfatin levels will be analysed through an ELISA kit Adipogen. In parallel, the levels of Visfatin will be evaluated in the maternal plasma/serum collected after 1-2 days postpartum.

Lastly, correlations between Visfatin levels and biological/clinical features of mothers and newborns will be explored.

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

  • Healthy male and female infants born after 37 weeks' gestation who do not have conditions related to congenital abnormalities
  • Maternal hospitalization
  • Acquisition of the informed consent form signed by the patient

排除标准

  • Refusal of the patient to participate in the study
  • Presence of hypogalactia or agalactia in the patient

结局指标

主要结局

Visfatin levels

时间窗: 1-2 days post-partum

Visfatin levels in maternal plasma/serum

次要结局

  • values of Visfatin(6 months)

研究者

发起方
Paolo Manzoni Study Group
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Paolo Manzoni Study Group

Principal Investigator, Head of Department of Maternal, Neonatal and Infant Medicine, Associate Professor

Paolo Manzoni

研究点 (1)

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