Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05729321
Status:
RECRUITING
Last Update Posted:
2023-02-16
First Post:
2023-02-06
Brief Title:
Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates a LOOSEN Pilot Study
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates a LOOSEN Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-02
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:
LOOSEN
Brief Summary:
Epicutaneo-caval catheters ECCs are widely used in neonatal intensive care units NICUs They are small catheters inserted via superficial veins of the limbs or scalp using direct vein visualization The pathogenic microorganisms colonized inside catheters can easily form a bacterial biofilm and eventually spread with blood flow which causes bloodstream infection Many authors have studied the antibiotic-lock therapy ALT in which a high-dose antibiotic solution is dripped and maintained in the catheter cavity for a certain period and can dissolve the biofilm formed on the wall to reduce the colonization of the bacteria and kill the embedded bacteriaThe aim of the study is to evaluate the patency of the Epicutaneo-caval catheter after its closure for 1 hour
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