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Clinical Trials/NCT03474978
NCT03474978
Recruiting
N/A

Peripherally Inserted Central Venous Catheter Insertion Site and Complication Rates in Neonates

University of Calgary1 site in 1 country320 target enrollmentOctober 19, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Catheterization, Peripheral
Sponsor
University of Calgary
Enrollment
320
Locations
1
Primary Endpoint
Primary outcome is the presence of any complication which necessitates PICC removal
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study examines whether there is an association between the PICC insertion site and the complications necessitating PICC removal in neonates admitted to neonatal intensive care unit.

Registry
clinicaltrials.gov
Start Date
October 19, 2018
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amuchou Soraisham

Neonatologist

University of Calgary

Eligibility Criteria

Inclusion Criteria

  • Neonates of all gestational ages admitted to Foothills Medical Centre and Alberta Children's Hospital Neonatal Intensive Care Unit (NICU)
  • Peripherally inserted central venous catheter (PICC) line insertion planned as part of NICU care
  • Venous access available in both upper(above umbilicus) and lower body

Exclusion Criteria

  • Local infection at potential site of insertion
  • Hemangioma, lymphangioma or malformations in the region of insertion
  • Major chromosomal anomalies

Outcomes

Primary Outcomes

Primary outcome is the presence of any complication which necessitates PICC removal

Time Frame: Through study completion, within 4 weeks

Line infiltration will be defined as extravasation of fluid into soft tissue around the region of the catheter tip. Line occlusion will be defined as inability to infuse fluid, resulting in removal of line. Phlebitis will be defined as presence of a linear red streak developing along the superficial veins from the catheter insertion site. Line associated thrombosis will be defined as ultrasound proven evidence of an occlusive thrombus in an anatomic location in proximity to the site of PICC.CLABSI will be defined according to Center for Disease Control definitions 26, that is, (1) confirmed primary bloodstream infection with (2) one of following clinical signs of infection (fever, hypothermia, apnea, or bradycardia) and (3) presence of central catheter at the time of or within 48 hours before the onset of the infection. Major life-threatening complications will include pleural effusion, pericardial effusion and cardiac tamponade, retroperitoneal extravasation.

Secondary Outcomes

  • Secondary outcome will be time to complication post insertion(Through study completion, within 4 weeks)

Study Sites (1)

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