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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04337307
Acronym
DECONTA
Enrollment
40
Registered
2020-04-07
Start date
2020-06-08
Completion date
2021-12-20
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Care Worker Patient Transmission

Keywords

Bacterial colonization of incubators

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.

Interventions

BIOLOGICALSkin 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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-

Design outcomes

Primary

MeasureTime frameDescription
Absence of bacterial contaminationDay 0 (just before the decontamination)Efficacy of decontamination will be defined for each incubator as the absence of bacterial contamination after the process of decontamination

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026