Peripherally Inserted Central Catheter Insertion Site and Complication Rate in Neonates

Catheterization, Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03474978
• Other study ID #: REB17-2371
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: Amuchou Soraisham, MD
• Phone: 403-944-8101
• Email: amuchou.soraisham[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

Inclusion Criteria:

1. Neonates of all gestational ages admitted to Foothills Medical Centre and Alberta Children's Hospital Neonatal Intensive Care Unit (NICU)

2. Peripherally inserted central venous catheter (PICC) line insertion planned as part of NICU care

3. Venous access available in both upper(above umbilicus) and lower body

Exclusion Criteria:

1. Local infection at potential site of insertion

2. Hemangioma, lymphangioma or malformations in the region of insertion

3. Major chromosomal anomalies

Related Conditions & MeSH terms

• Catheterization, Peripheral

Intervention

Device:
• Peripherally Inserted Central Venous Cather (PICC)
Location of the PICC insertion will be randomized and compared

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary outcome will be time to complication post insertion	This will be defined as the interval between PICC line insertion and first detection of complication post insertion, expressed in days.	Through study completion, within 4 weeks