Clinical trial NCT06391463: Multi-resistant and Spore-forming Bacteria in a Neonatal Intensive Care Unit
Official title: Analysis of the Presence of Multi-resistant and Spore-forming Bacteria in a Neonatal Intensive Care Unit: Implications for Practice
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Multidrug Resistant Bacterial Infection
Keywords: multidrug-resistant bacteria
neonatology
spore-forming bacteria
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 1500
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn hospitalized in the neonatology service of Croix Rousse hospital with at least one coproculture

Brief summary: Preventing the spread of multidrug-resistant bacteria (MRB) is a major challenge for hospitals today. MRB are defined as bacteria that combine several resistance mechanisms to different families of antibiotics, thus limiting therapeutic possibilities in the event of infection.

The spread of MRBs is particularly prevalent in hospital units caring for fragile patients, such as neonatal units. Preventing the spread of MRBs is of prime importance in these units, in order to limit the number of infections caused by these germs. Newborns are at risk of infection due to intrinsic factors such as an immature immune system and fragile skin, as well as extrinsic factors such as mechanical ventilation and intravascular catheters.

In Germany, a 2012 KRINKO agreement encourages neonatal units to monitor MRB carriage on a weekly basis. This measure enables early detection of MRB colonization outbreaks in neonatal units. In France, MRB carriage monitoring in neonatal units is not systematic.

Spore-forming bacteria also require close monitoring in neonatology, as they do not strictly meet the definition of MRB, but represent a major threat to newborns. The main spore-forming bacterium of medical interest is Bacillus cereus (BC), which is responsible for serious infections in premature infants. BC is resistant to the use of hydro-alcoholic solutions. The origin of these BC infections remains controversial, with numerous studies in the international literature suggesting a link between BC infections and contamination of breast milk given to infants in neonatal units. The role of environmental contamination has also been studied. The potential seriousness of these BC infections justifies the systematic detection of the carriage of this spore-forming bacterium in routine coprocultures, in the same way as other MRB germs.

In the neonatal unit at Hôpital de la Croix Rousse, MRB and BC are routinely tested on patient arrival, and then weekly until discharge.

If MRB or BC germs are found in children's stools reinforced specific hygiene measures are implemented to prevent cross-transmission in this open-bay unit with little space between incubators. Reinforced specific hygiene measures represent a time constraint for the nursing team, for parents and a financial burden for the neonatal unit. However, to our knowledge, there are no international or national recommendations concerning the duration of stools reinforced specific hygiene measures. Our clinical experience has shown that the persistence of pathogenic germs in stools seems to vary in duration depending on the microorganism.

To better determine the optimal duration of reinforced specific hygiene measures, as it is costly in terms of work time, parental stress, and hospital expenses due to reinforced hygiene conditions during the isolation period.


Eligibility criteria: * Inclusion Criteria \* :

  * Children hospitalized in the department of neonatology at croix rousse university hospital
  * With at least one coproculture
* Exclusion Criteria \* :

  * Death or discharge of the patient before the first stool culture has been taken
  * Impossibility for the laboratory to interpret the stool culture in a patient in whom only one stool culture has been taken, or recurrence of impossibility to interpret all stool cultures from the same patient.

Primary outcomes:
measure: Determine the number of patients carrying BMR and BC germs
timeFrame: up to 4 months postnatal age or discharge which comes first
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Croix Rousse
Study officials:
References: