Peripherally Inserted Central Catheter Insertion Site and Complication Rate in Neonates

Study Overview
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Brief Summary
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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.

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

Conditions
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Catheterization, Peripheral

Intervention / Treatment
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* Device: Peripherally Inserted Central Venous Cather (PICC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upper Extremity Insertion<br>Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity | Device: Peripherally Inserted Central Venous Cather (PICC)<br>* Location of the PICC insertion will be randomized and compared<br>|
| Experimental: Lower Extremity Insertion<br>Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity | Device: Peripherally Inserted Central Venous Cather (PICC)<br>* Location of the PICC insertion will be randomized and compared<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |