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

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

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.

Study Overview

• Status: Completed
• Conditions: Health Care Worker Patient Transmission
• Intervention / Treatment: Biological: Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hopital Femme Mere Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthcare workers of the NICU of the Hopital Femme Mere enfant (HFME), Hospices Civils de Lyon, that will be involved in the process of decontamination of the incubators during the study period.

Description

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-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
standard decontamination; incubators decontaminated with antiseptic molecules, healthcare workers involved in this decontamination, patients housed in these incubators	Biological: Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators; Each incubator will be sampled in 5 points before and after decontamination. The healthcare worker that will be involved in the decontamination will also be sampled (skin sample of the hand) before and after decontamination of the incubator. All the samples will be analyzed for the presence of pathogenic bacteria, using an inoculation on selective agar then an identification of each bacterial colony.
steam pulverization; incubators decontaminated with steam pulverization, healthcare workers involved in this decontamination, patients housed in these incubators	Biological: Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators; Each incubator will be sampled in 5 points before and after decontamination. The healthcare worker that will be involved in the decontamination will also be sampled (skin sample of the hand) before and after decontamination of the incubator. All the samples will be analyzed for the presence of pathogenic bacteria, using an inoculation on selective agar then an identification of each bacterial colony.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of bacterial contamination	Efficacy of decontamination will be defined for each incubator as the absence of bacterial contamination after the process of decontamination	Day 0 (just before the decontamination)
Absence of bacterial contamination	Efficacy of decontamination will be defined for each incubator as the absence of bacterial contamination after the process of decontamination	Day 0 (just after the decontamination)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Bacterial colonization of incubators
• Other Study ID Numbers: 69HCL20_0299; ID-RCB (Other Identifier: 2023-A01937-38)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No