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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05729321

Acronym

LOOSEN

Enrollment

Registered

2023-02-15

Start date

2022-09-01

Completion date

2023-09-01

Last updated

2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Complications, Catheter Infection, Catheter-related Bloodstream Infection, Preterm

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.

Interventions

COMBINATION_PRODUCTneutrox

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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. \-

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026