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Clinical Trials/NCT04337307
NCT04337307
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country40 target enrollmentJune 8, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Care Worker Patient Transmission
Sponsor
Hospices Civils de Lyon
Enrollment
40
Locations
1
Primary Endpoint
Absence of bacterial contamination
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 8, 2020
End Date
December 20, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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-

Outcomes

Primary Outcomes

Absence of bacterial contamination

Time Frame: 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

Study Sites (1)

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