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

Health Care Worker Patient Transmission Clinical Trial

— DECONTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337307
• Other study ID #: 69HCL20_0299
• Secondary ID: ID-RCB
• Status: Completed
• Start date: June 8, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: July 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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-

Related Conditions & MeSH terms

• Health Care Worker Patient Transmission

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)