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OpenTrials
Completed

NCT Number: NCT04337307

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

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.

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Key information

Conditions

Health Care Worker Patient Transmission

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Femme Mère Enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

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.

Primary outcomes

  1. Absence of bacterial contamination

    Time frame: Day 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

  2. Absence of bacterial contamination

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: DECONTA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2020
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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