Clinical trial NCT05729321: Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study
Official title: Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Catheter-related Bloodstream Infection
Preterm
Catheter Infection
Catheter Complications
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All infants who have catheters that need to be removed electively.

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 bacteria.The aim of the study is to evaluate the patency of the Epicutaneo-caval catheter after its closure for 1 hour.


Eligibility criteria: Inclusion Criteria:

All the Epicutaneo-caval catheter that need to be removed electively will be included in the study -

Exclusion Criteria:

All the Epicutaneo-caval catheters removed not electively but for infectious or mechanical complications will be excluded from the study.

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Primary outcomes:
measure: Pressure level mmHg
timeFrame: 1 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCSS
state: Itsly
city: Rome
country: Italy
facility: FPGemelliIRCCS
Study officials:
References:
citation: Jain A, Deshpande P, Shah P. Peripherally inserted central catheter tip position and risk of associated complications in neonates. J Perinatol. 2013 Apr;33(4):307-12. doi: 10.1038/jp.2012.112. Epub 2012 Sep 6.
citation: Barone G, Pittiruti M. Epicutaneo-caval catheters in neonates: New insights and new suggestions from the recent literature. J Vasc Access. 2020 Nov;21(6):805-809. doi: 10.1177/1129729819891546. Epub 2019 Dec 5.
citation: Barone G, Pittiruti M, Biasucci DG, Elisei D, Iacobone E, La Greca A, Zito Marinosci G, D'Andrea V. Neo-ECHOTIP: A structured protocol for ultrasound-based tip navigation and tip location during placement of central venous access devices in neonates. J Vasc Access. 2022 Sep;23(5):679-688. doi: 10.1177/11297298211007703. Epub 2021 Apr 5.
citation: Viale P, Pagani L, Petrosillo N, Signorini L, Colombini P, Macri G, Cristini F, Gattuso G, Carosi G; Italian Hospital and HIV Infection Group. Antibiotic lock-technique for the treatment of catheter-related bloodstream infections. J Chemother. 2003 Apr;15(2):152-6. doi: 10.1179/joc.2003.15.2.152.
citation: Dumichen MJ, Seeger K, Lode HN, Kuhl JS, Ebell W, Degenhardt P, Singer M, Geffers C, Querfeld U. Randomized controlled trial of taurolidine citrate versus heparin as catheter lock solution in paediatric patients with haematological malignancies. J Hosp Infect. 2012 Apr;80(4):304-9. doi: 10.1016/j.jhin.2012.01.003. Epub 2012 Feb 18.