Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT03474978

Conditions

Catheterization, Peripheral

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Peripherally Inserted Central Venous Cather (PICC)

Study Details

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

Study ID

NCT03474978

Start date

Oct 19, 2018

Status verified date

May, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Upper Extremity Insertion

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

experimental: Lower Extremity Insertion

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

Interventions

Peripherally Inserted Central Venous Cather (PICC)

Location of the PICC insertion will be randomized and compared

Primary outcome measure

  • Primary outcome is the presence of any complication which necessitates PICC removal [ Time Frame: Through study completion, within 4 weeks ]

Central Contacts and Locations

Central contacts

Amuchou Soraisham, MD

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

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N2T9

Contacts

Amuchou Soraisham, MD, DM, FRCPC

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

Harish Amin, MBBS, FRCPC

403-955-7513harish.amin@ahs.ca

Principal Investigator:

Amuchou Soraisham, MD

More Information

Sponsor

University of Calgary

Last update posted

May 19, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2023-05-19.