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

NCT07209670 | Not Yet Recruiting

• 1 other identifier: venous catheters in neonates
• Study Type: observational
• Target: 360
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• catheter survival time

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

  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)

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

Study Arms (2)

UVC group

UVC Group: Neonates who received umbilical venous catheters within the first 28 days of life.

Procedure: umbilical venous catheters insertion

PICC group

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

Procedure: peripherally inserted central catheter insertion

Interventions

peripherally inserted central catheter insertion PROCEDURE

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

PICC group

umbilical venous catheters insertion PROCEDURE

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

UVC group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-09