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临床试验/CTRI/2014/11/005199
CTRI/2014/11/005199已完成4 期

An observational study to characterize human milk of mothers delivering term SGA and AGA infants

estec Ltd0 个研究点目标入组 142 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
142

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1.All mothers who delivered term infants, either SGA or AGA
  • 2.Mothers between 18 and 40 years of age inclusive, at the time of enrolment
  • 3.Having decided to predominantly breast-feed their new born baby at least until 6 months of age
  • 4.Having permanent residence at a maximum distance of 50km from the hospital/center of investigation for the duration of this study and being able to follow all the steps of this study
  • 5.Willing to provide informed consent according to the requirements of local regulations.

排除标准

  • 1.Preterm delivery (<= 36 weeks + 6 days completed) of gestational age)
  • 2.Currently participating or having participated in an interventional clinical trial during the last 4 weeks prior to the beginning of this study
  • 3.Having a BMI >= 25.0
  • 4.Chewing tobacco, smoking or drinking alcohol ( > 1 glass per day), consuming illicit drugs during pregnancy or/and duration of the study
  • 5.Presenting any disease or medical condition which might prevent breast-feeding or collecting the human milk samples or for which breast-feeding is contraindicated
  • 6.Having diabetes or gestational diabetes mellitus
  • 7.Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease
  • 8.Subject unable to comply with study procedures or unable to come to hospital for the study visits.

研究者

发起方
estec Ltd

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