Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study

Preterm Clinical Trial

— LOOSEN  

Official title:

Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05729321
• Other study ID #: 4880
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: September 1, 2023
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Catheter Complications
• Catheter Infection
• Catheter-related Bloodstream Infection
• Communicable Diseases
• Infections
• Preterm
• Sepsis

Intervention

Combination Product:
• neutrox
Each ECC, after discontinuing the Parental Nutrition (NP) infusion, will be flushed with 0.3 ml saline. Subsequently, Saline will be infused at a rate of 2 ml/h for 10 minutes. The ECC will then be closed for 1 hour. At the end of the hour the ECC will be once again flushed with 0.3 ml Saline and infused with SF at the rate of 2 cc/h for 10 minutes. The difference in pressure of the two infusions, before and after catheter closure, will be evaluated.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCSS	Roma	Itsly
Italy	FPGemelliIRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure level mmHg	The aim of the study is to evaluate the patency of the Epicutaneo-caval catheter after its closure for 1 hour.	1 hours