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Procedure
PICC Placement for Peripheral Catheterization in Newborns
N/A
Recruiting
Led By Amuchou Soraisham, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Peripherally inserted central venous catheter (PICC) line insertion planned as part of NICU care
Neonates of all gestational ages admitted to Foothills Medical Centre and Alberta Children's Hospital Neonatal Intensive Care Unit (NICU)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, within 4 weeks
Awards & highlights
Study Summary
This trial studies how PICC insertion site affects complications that require removal in newborns in the NICU.
Who is the study for?
This trial is for newborns of any gestational age in the NICU at Foothills Medical Centre and Alberta Children's Hospital who need a PICC line as part of their care. They must have available veins for insertion both above and below the umbilicus.Check my eligibility
What is being tested?
The study is looking into whether where the PICC line is put in (either upper or lower body) affects how often complications happen that make doctors have to take out the PICC line.See study design
What are the potential side effects?
While not explicitly listed, common side effects from PICC insertions can include infection, irritation at the insertion site, blood clots, and possibly injury to nerves or vessels near the insertion area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby is in the NICU and will have a PICC line inserted.
Select...
My newborn is admitted to the NICU at Foothills Medical Centre or Alberta Children's Hospital.
Select...
I have veins in both my upper and lower body that can be used for medical procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, within 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, within 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
is the presence of any complication which necessitates PICC removal
Secondary outcome measures
will be time to complication post insertion
Trial Design
2Treatment groups
Experimental Treatment
Group I: Upper Extremity InsertionExperimental Treatment1 Intervention
Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity
Group II: Lower Extremity InsertionExperimental Treatment1 Intervention
Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
868,834 Total Patients Enrolled
Amuchou Soraisham, MDPrincipal InvestigatorUniversity of Calgary
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an infection where they might insert a medical device.I have a benign tumor or malformation where the medical device will be inserted.My baby is in the NICU and will have a PICC line inserted.My condition involves significant genetic abnormalities.My newborn is admitted to the NICU at Foothills Medical Centre or Alberta Children's Hospital.I have veins in both my upper and lower body that can be used for medical procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Upper Extremity Insertion
- Group 2: Lower Extremity Insertion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of participants in this clinical experiment?
"Indeed, clinicaltrials.gov is advertising this medical trial and its need for 320 patients at 1 site. The study was posted on October 19th 2018 and has been recently updated as of May 17th 2023."
Answered by AI
Is this medical research still accepting participants?
"Affirmative. Per the details provided on clinicaltrials.gov, this research is currently taking applications for participation. The trial was initially made public on October 19th 2018 and last modified on May 17th 2023. A total of 320 subjects are needed from one specific site.."
Answered by AI
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