跳至主要内容
临床试验/NCT04972214
NCT04972214Unknown不适用

The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome

CHA University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年5月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
intestinal microbiome composition according to the type of feeding

研究概览

简要总结

This study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula)

详细描述

The gut microbiome has been increasingly found to affect human health. Feeding plays an important role in determining the composition and diversity of the neonatal gut microbiome. Preterm infants are at a high risk of gut microbiota disruption and dysbiosis because of physiological immaturity and environmental factors. In preterm infants, breast milk has been associated with improved growth and cognitive development and a reduced risk of necrotizing enterocolitis and late onset sepsis.

The objective of study is to determine the impact of feeding type on gut microbiome of very preterm infants admitted in a neonatal intensive care unit (NICU). Meconium and the additional 2 fecal samples will be collected from preterm infants. Fecal samples will be collected every 14 days, during 28 days, from diapers into sterile tubes. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.

The type of infant feeding (breast milk or preterm formula) is recorded daily to classify the type of infant feeding received during the 14 days prior to each fecal sample collection.

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

  • Very preterm infants (< 32 weeks gestational age) admitted in the NICU of CHA Bundang Medical Center within the first 24 hours after birth

排除标准

  • Parents refuse to participate/sign informed consent
  • Major congenital anomalies

结局指标

主要结局

intestinal microbiome composition according to the type of feeding

时间窗: 4 weeks after birth

comparison of intestinal microbiome with 16s RNA gene specific sequencing

次要结局

未报告次要终点

研究者

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

Hye-Rim Kim

professor

CHA University

研究点 (1)

Loading locations...

相似试验