Clinical trial

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

Name

4880

Description

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.

Trial arms

Trial start

2022-09-01

Estimated PCD

2022-11-05

Trial end

2023-09-01

Status

Recruiting

Treatment

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.

Arms:

Epicutaneo-caval catheter removed electively

Size

Primary endpoint

Pressure level mmHg

1 hours

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. -

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 7, 'type': 'ESTIMATED'}}

Updated at

2023-02-16

1 organization

1 product

4 indications

Organization

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Product

neutrox

Indication

Catheter-Related Bloodstream Infection

Indication

Preterm

Indication

Catheter-related bloodstream infection

Indication

Complications of Catheterization