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临床试验/NCT02830503
NCT02830503已完成不适用

Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life: A Randomized Controlled Trial

Gorm Greisen1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Concentration (CFU/ml) of bacteria in gastric aspirates

研究概览

简要总结

Project summary

Rationale

Many NICU's replace their feeding tubes once a week or more rarely in order to avoid disturbing the infants. The researchers discovered that there are high concentrations of potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even within one day of use (own data, manuscript submitted). Preterm infants are vulnerable to the colonization of the gut, and development of dysbiosis might lead to necrotizing enterocolitis. The researchers speculate if replacing the resident feeding tube every day and thereby decreasing the amount of potentially pathogenic bacteria given to the infants via the feeding tube will lead to fewer bacteria present in the upper part of the gastrointestinal tract of the infant and hence a reduced competition with probiotic colonization.

Objectives

The investigators plan to conduct an intervention study in premature infants receiving probiotics (< 32 weeks of gestation) where the feeding tube will be replaced every day in the intervention group and once a week (standard practice) in the control group. The main outcome will be bacterial concentration in the stomach after one week of life.

Methods

The study is a prospective, randomized controlled trial in preterm infants. Infants will be randomized to the intervention group in which the tube is replaced every day or the control group which will follow normal practice in the department. The intervention will last one week. The infants will be followed until discharge. The investigators plan to include 11 infants in each group.

Primary outcome

Concentration of bacteria in gastric aspirates on day seven.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Hour 至 48 Hours(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Under 32 weeks GA at birth
  • •Admission time considered to be more than seven days
  • •Signed informed consent within 48 hours after birth

排除标准

  • •Transfer to another hospital within seven days
  • •Major gastrointestinal malformations
  • •No tube feeding within first 48 h of birth

研究组 & 干预措施

Intervention

Experimental

Feeding tube daily replacement

干预措施: Feeding tube daily replacement (Procedure)

Control

No Intervention

Feeding tubes replaced as normal practice in the department (normally once a week).

结局指标

主要结局

Concentration (CFU/ml) of bacteria in gastric aspirates

时间窗: on day seven of life

次要结局

  • Number of patients with potentially pathogenic bacteria at any concentration in gastric aspirates(day seven of life.)
  • pH (acidity) of gastric aspirates(First week of life)
  • Concentration (CFU/ml) of bacteria in maternal milk(First week of life)
  • Number of patients with probiotics cultured from gastric aspirates aspirates(First week of life)

研究者

发起方
Gorm Greisen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gorm Greisen

Professor

Rigshospitalet, Denmark

研究点 (1)

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