Decontamination of Incubators in a NICU (Neonatal Intensive Care Unit)

Completed

• Conditions: Health Care Worker Patient Transmission
• Interventions: Biological: Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators

• Registration Number: NCT04337307
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-07
• Study Start: 2020-06-08
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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-

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
standard decontamination	Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators	incubators decontaminated with antiseptic molecules, healthcare workers involved in this decontamination, patients housed in these incubators
steam pulverization	Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators	incubators decontaminated with steam pulverization, healthcare workers involved in this decontamination, patients housed in these incubators

Primary Outcome Measures

Name	Time	Method
Absence of bacterial contamination	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

Trial Locations

Locations (1)

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France