跳至主要内容
临床试验/NCT04337307
NCT04337307已完成不适用

Evaluation of Two Procedures of Incubator's Decontamination in a NICU

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Absence of bacterial contamination

研究概览

简要总结

Nosocomial infections are responsible for morbidity and mortality in hospitalized neonates. The environment of the neonates and especially the incubators can constitute the reservoir of pathogenic bacteria. That is why decontamination of incubators is a major step in the fight against nosocomial infections in NICUs.

The hypothesize is that the usual procedure of decontamination, based on antiseptic molecules, is not sufficient to eradicate all pathogenic bacteria from the incubators.

In this study the investigator's aim to assess the efficacy of the usual procedure of decontamination and to compare it with another procedure based on steam pulverization. Another objective will be to explore a possible contamination of the hands of the healthcare workers, that can be involved in the cycle of transmission of bacteria to neonates. Finally, clinical data about the neonates housed in the incubator will be retrieved from clinical reports, to identify the occurrence of sepsis and if so, to compare the bacteria involved in the sepsis and the bacteria present in the incubator.

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

  • Healthcare workers involved in the decontamination process of incubators during the study period (period of sampling of incubators before and after decontamination)
  • The two people involved in the sampling of incubators
  • The patients (neonates) that will be housed in one incubator decontaminated and sampled during the study period

排除标准

  • Refusal to participate for healthcare workers and people involved in the sampling
  • Refusal to give access to the clinical data of his child for the parent of the patients included in the study-

结局指标

主要结局

Absence of bacterial contamination

时间窗: Day 0 (just after the decontamination)

Efficacy of decontamination will be defined for each incubator as the absence of bacterial contamination after the process of decontamination

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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