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

NCT04337307 | Completed

• 2 other identifiers: 69HCL20_0299ID-RCB
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Worker Patient Transmission

Keywords

Bacterial colonization of incubators

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

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

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

Interventions

Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators BIOLOGICAL

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.

standard decontamination; steam pulverization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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-

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 7, 2020
• Study Start: June 8, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

FR (1)