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临床试验/NCT03235635
NCT03235635Unknown不适用

Metagenome Analysis of Intestinal Microbiome in Mortality and Morbidity of Preterm Infants

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年7月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Intestinal microbiome

研究概览

简要总结

This is single center study. The investigators will try to know that relationships between intestinal microbiome and mortality in preterm infants and what relationships is between intestinal microbiome in preterm infants and morbidity, mortality.

详细描述

Microbiome is the collection of all the microorganisms living in association with the human body which are consist of eukaryotes, archaea, bacteria and viruses. Microbiome in an average human body number are ten times more than human cells and have about 1000 more genes than are present in the human genome. There are symbiotic relationships between human and microbiome. If investigators are able to know about relationships between newborn and intestinal microbiome, mortality and morbidity in preterm infants may be improved. The investigators will collect the first and weekly stool of participants and analyze DNA of microbiome thorough Metagenomic anlysis. The results between 3 groups(preterm, late preterm and full-term infants) will be compared. The investigators expect that a mean distribution of intestinal microbiome in newborns(preterm, late preterm and full-term) is defined and that relationships between mortality, morbidity and intestinal microbiome.

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
1 Day 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • preterm infants who were born at gestational age of less than 36 weeks from approval date to Feb 28th 2019
  • full-term infants who were born at gestational age of greater than 37 weeks from approval date to Feb 28th 2019

排除标准

  • newborns with congenital anomaly
  • newborns with genetic syndrome
  • newborns without consent of parents

结局指标

主要结局

Intestinal microbiome

时间窗: for 2 years

The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment which is one of the analysis in result of metagenomics in each infants

次要结局

  • Mortality(for 2 years)
  • Full Enteral feeding in preterm infants(for 2 years)
  • Growth rate(for 2 years)
  • Morbidity(for 2 years)
  • Allergic predisposition(for 2 years)

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Byoungkook Lee

assistant professor

Wonju Severance Christian Hospital

研究点 (1)

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