跳至主要内容
临床试验/NCT02502916
NCT02502916已完成不适用

Potential Role of the Enteral Feeding Systems on Early Bacterial Gut Colonization of Preterm Infants

Universidad Complutense de Madrid0 个研究点目标入组 32 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
主要终点
Number of infants sharing bacterial strains with the milk received by each one

研究概览

简要总结

The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.

详细描述

First spontaneously evacuated meconium and fecal samples were collected by the medical staff of the Hospital weekly from the diapers of the infants during their stay at the Neonatal Intensive Care Unit.

To evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured.

Later, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months.

研究设计

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

入排标准

年龄范围
2 Hours 至 8 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age of less than 32 weeks or with birth weight of less than 1,200 g

排除标准

  • any malformation or suffering from any genetic metabolic disorder

结局指标

主要结局

Number of infants sharing bacterial strains with the milk received by each one

时间窗: two years

The meconium and fecal samples of the infants have been analysed microbiologically. In parallel, own's mother milk, donor milk and formula milk have been analyzed microbiologically after their pass through the nasogastric feeding tube. The bacterial strains isolated from fecal samples of each infant have been compared with the bacterial strains isolated from the milk that have received each of them.

次要结局

  • Number of bacterial strains shared by each infant and the milk received.(two years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan M. Rodríguez

Professor

Universidad Complutense de Madrid

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