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NCT Number: NCT07209670

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

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

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Key information

Conditions

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

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peripherally inserted central catheter insertion

Procedure

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

umbilical venous catheters insertion

Procedure

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

Primary outcomes

  1. catheter survival time

    Time frame: From 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

  2. Central Line-Associated Bloodstream Infection (CLABSI) Incidence

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

    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)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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