Health Care Worker Patient TransmissionDECONTANCT04337307
Decontamination of Incubators in a NICU (Neonatal Intensive Care Unit)
An observational study of Health Care Worker Patient Transmission, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Care Worker Patient Transmission
- What is being tested?
- Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2020to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Health Care Worker Patient Transmission
- Being tested
- Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators
- Keywords
- Bacterial colonization of incubators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin sampling of the hands of the healthcare workers involved in the decontamination of incubatorsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| standard decontamination | incubators decontaminated with antiseptic molecules, healthcare workers involved in this decontamination, patients housed in these incubators Receives: 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 Receives: Biological: Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of bacterial contamination
Efficacy of decontamination will be defined for each incubator as the absence of bacterial contamination after the process of decontamination
Measured: 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
Measured: Day 0 (just after the decontamination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start8 Jun 2020
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care Worker Patient TransmissionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337307
- Sponsor's protocol ID
- 69HCL20_0299
- Other IDs
- ID-RCB
- Acronym
- DECONTA
- Status last verified
- Jul 2022
- First submitted
- 2 Apr 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Procedures of Incubator's Decontamination in a NICU
- ClinicalTrials.gov ID
- NCT04337307
- Acronym / sponsor ID
- DECONTA / 69HCL20_0299
- Conditions
- Health Care Worker Patient Transmission
- Keywords
- Bacterial colonization of incubators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard decontamination | – | Biological: Skin sampling of the hands of the healthcare workers involved in the decontamination of incubatorsincubators decontaminated with antiseptic molecules, healthcare workers involved in this decontamination, patients housed in these incubators |
| steam pulverization | – | Biological: Skin sampling of the hands of the healthcare workers involved in the decontamination of incubatorsincubators decontaminated with steam pulverization, healthcare workers involved in this decontamination, patients housed in these incubators |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin sampling of the hands of the healthcare workers involved in the decontamination of incubatorsEach 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. | Biological | standard decontamination, steam pulverization |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Care Worker Patient Transmission, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of bacterial contamination (time frame: Day 0 (just before the decontamination)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.