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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07209670
Enrollment
360
Registered
2025-10-07
Start date
2025-12-01
Completion date
2028-12-20
Last updated
2025-10-07

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

Conditions

CLABSI - Central Line Associated Bloodstream Infection, Peripherally Inserted Central Catheter, Umbilical Venous Catheter

Brief summary

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

Interventions

PROCEDUREperipherally inserted central catheter insertion

Neonates who received peripherally inserted central catheters within the first 28 days of life.

PROCEDUREumbilical venous catheters insertion

Neonates who received umbilical venous catheters within the first 28 days of life

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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. * Cases with incomplete clinical records or missing follow-up data.

Design outcomes

Primary

MeasureTime frameDescription
catheter survival timeFrom catheter insertion until removal (up to 28 days of life or until hospital discharge, whichever occurs first)Number of days each catheter remains functional and in use before removal
Central Line-Associated Bloodstream Infection (CLABSI) IncidenceDuring the entire catheterization period (up to 28 days of life or until hospital dischargeNumber 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)

Outcome results

None listed

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