Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391463
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-30
First Post:
2024-03-04
Brief Title:
Multi-resistant and Spore-forming Bacteria in a Neonatal Intensive Care Unit
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Analysis of the Presence of Multi-resistant and Spore-forming Bacteria in a Neonatal Intensive Care Unit Implications for Practice
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEOBIOTA
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 childrens 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
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 childrens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None