Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort Study of Complications, Catheter Survival, and CLABSI"

ConditionsPeripherally Inserted Central Catheter Umbilical Venous Catheter CLABSI - Central Line Associated Bloodstream Infection

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age0-28

SponsorAssiut University

About this trial

This study aims to prospectively compare umbilical venous catheters (UVCs) and peripherally inserted central catheters (PICCs) in neonates, focusing on complications, catheter survival, and central line-associated bloodstream infection (CLABSI) rates

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Neonates admitted to the neonatal intensive care unit (NICU) requiring central venous access.

Infants in whom either an umbilical venous catheter (UVC) or a peripherally inserted central catheter (PICC) was inserted for clinical indications (Parenteral nutrition, administration of intravenous medications (e.g., antibiotics, inotropes, anticonvulsants, fluids) and blood sampling for frequent labs, especially in critically ill neonates).

Catheter insertion performed within the first 28 days of life.

Disqualifiers

Neonates with major congenital anomalies (e.g.abdominal wall defects) that may interfere with catheter placement or outcomes.

Insertion site infection

Infants with severe coagulopathy or bleeding disorders contraindicating central catheter insertion.

Neonates who received both UVC and PICC simultaneously during the same admission.

Trial population

Neonates admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children's Hospital who require central venous access for parenteral nutrition, intravenous medications, or frequent blood sampling. Participants will include infants receiving either an umbilical venous catheter (UVC) or a peripherally inserted central catheter (PICC) within the first 28 days of life

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

peripherally inserted central catheter insertion
Procedure/Surgery
Neonates who received peripherally inserted central catheters within the first 28 days of life.
umbilical venous catheters insertion
Procedure/Surgery
Neonates who received umbilical venous catheters within the first 28 days of life

Treatment groups

360 Participants

are divided into 2 treatment groups

Group A: UVC group1 intervention

Group B: PICC group1 intervention

Trial outcomes

Primary outcomes

catheter survival time

Number of days each catheter remains functional and in use before removal

Time frame

From catheter insertion until removal (up to 28 days of life or until hospital discharge, whichever occurs first)

Central Line-Associated Bloodstream Infection (CLABSI) Incidence

Number of CLABSI events per 1,000 catheter-days, diagnosed according to CDC/NHSN criteria (positive blood culture + clinical signs of sepsis with no other source)

Time frame

During the entire catheterization period (up to 28 days of life or until hospital discharge

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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