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临床试验/NCT07098377
NCT07098377进行中(未招募)不适用

Gut, Nasopharyngeal, and Skin Microbiota in Children With Severe Burn Injury: the Role in Infectious Complications in Burn Injury

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
intestinal microbiota variation in burnt children

研究概览

简要总结

The research protocol consists of taking aliquots of biological specimens from skin swabs, nasopharyngeal swabs, and fecal swabs. the samples will be taken at time 0 of admission to the Pediatric ICU, one week after admission, and two weeks after admission to compare the bacterial populations present at the different sampling sites.

详细描述

Pediatric burns (0-14 years) make up 26% of emergency room admissions for burns, with 73% of cases in children under 5 years old. The most common burns are thermal from boiling liquids, followed by open flames and fireworks. Severe burns (>20% of body surface area) provoke a systemic inflammatory response that causes hypovolemia, tissue hypoperfusion, and metabolic stress, establishing a vicious cycle that is difficult to break.

Burn trauma can also compromise the intestinal barrier, composed of cellular junctions (tight junctions), damage to which increases intestinal permeability. This promotes the passage of luminal contents into the systemic circulation, aggravating the immune and inflammatory response. Gut dysfunction is often accompanied by dysbiosis of the microbiota, with risk of bacterial translocation to sterile organs (liver, lungs, brain), contributing to systemic complications in critically ill patients.

The study hypothesizes that burn trauma increases intestinal permeability, promoting bacterial translocation and anticipating infectious complications. Analyzing microbial populations at exposed sites (skin, gut, BAL) during trauma and pediatric ICU care may help to better understand the origin of septic complications.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • signs and/or symptoms of burn injury

排除标准

  • major congenital malformation
  • Antibiotic treatment 48 hours prior to admission
  • failure to provide informed consent to participate in the protocol

结局指标

主要结局

intestinal microbiota variation in burnt children

时间窗: 21 days

concentration of microbiota population in pediatric population severely burnt

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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