Peripherally Inserted Central Catheter Insertion Site and Complication Rate in Neonates

NCT03474978 | Unknown

• 1 other identifier: REB17-2371
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheterization, Peripheral

Outcome Measures

Primary Outcomes (1)

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

  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.

  Through study completion, within 4 weeks

Secondary Outcomes (1)

• Secondary outcome will be time to complication post insertion

  Through study completion, within 4 weeks

Study Arms (2)

Upper Extremity Insertion

EXPERIMENTAL

Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity

Device: Peripherally Inserted Central Venous Cather (PICC)

Lower Extremity Insertion

EXPERIMENTAL

Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity

Device: Peripherally Inserted Central Venous Cather (PICC)

Interventions

Peripherally Inserted Central Venous Cather (PICC) DEVICE

Location of the PICC insertion will be randomized and compared

Lower Extremity Insertion; Upper Extremity Insertion

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

RECRUITING

Study Officials

• Amuchou Soraisham, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amuchou Soraisham, MD

CONTACT

403-944-8101; amuchou.soraisham@ahs.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 23, 2018
• Study Start: October 19, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

CA (1)