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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper Extremity Insertion | Experimental | Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity |
|
| Lower Extremity Insertion | Experimental | Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripherally Inserted Central Venous Cather (PICC) | Device | Location of the PICC insertion will be randomized and compared |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amuchou Soraisham, MD | Contact | 403-944-8101 | amuchou.soraisham@ahs.ca |
| Name | Affiliation | Role |
|---|---|---|
| Amuchou Soraisham, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Recruiting | Calgary | Alberta | T2N2T9 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2017 | Mar 1, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 2, 2018 | Mar 14, 2018 | ICF_001.pdf |
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