Catheterization, PeripheralNCT03474978
Peripherally Inserted Central Catheter Insertion Site and Complication Rate in Neonates
A study testing Peripherally Inserted Central Venous Cather (PICC) in people with Catheterization, Peripheral, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Catheterization, Peripheral
- What is being tested?
- Peripherally Inserted Central Venous Cather (PICC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteCanada
- Study dates
- 19 Oct 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Local infection at potential site of insertion
- Hemangioma, lymphangioma or malformations in the region of insertion
- Major chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N2T9
Amuchou Soraisham, MD, DM, FRCPC, 403-944-8101, amuchou.soraisham@ahs.ca
Harish Amin, MBBS, FRCPC, 403-955-7513, harish.amin@ahs.ca
About this study
Official title: Peripherally Inserted Central Venous Catheter Insertion Site and Complication Rates in Neonates
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
- Being tested
- Peripherally Inserted Central Venous Cather (PICC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripherally Inserted Central Venous Cather (PICC)Device
Location of the PICC insertion will be randomized and compared
| Study group | Role | What they receive |
|---|---|---|
| Upper Extremity Insertion | Experimental | Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity Receives: Device: Peripherally Inserted Central Venous Cather (PICC) |
| Lower Extremity Insertion | Experimental | Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity Receives: Device: Peripherally Inserted Central Venous Cather (PICC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, within 4 weeks
Secondary outcomes (1)
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.
Measured: Through study completion, within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start19 Oct 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amuchou Soraisham, University of Calgary
- Investigators
- Amuchou Soraisham, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474978
- Sponsor's protocol ID
- REB17-2371
- Status last verified
- May 2023
- First submitted
- 14 Mar 2018
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripherally Inserted Central Venous Catheter Insertion Site and Complication Rates in Neonates
- ClinicalTrials.gov ID
- NCT03474978
- Acronym / sponsor ID
- REB17-2371
- Conditions
- Catheterization, Peripheral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Extremity Insertion | Experimental | Device: Peripherally Inserted Central Venous Cather (PICC)Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity |
| Lower Extremity Insertion | Experimental | Device: Peripherally Inserted Central Venous Cather (PICC)Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Local infection at potential site of insertion
- Hemangioma, lymphangioma or malformations in the region of insertion
- Major chromosomal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripherally Inserted Central Venous Cather (PICC)Location of the PICC insertion will be randomized and compared | Device | Lower Extremity Insertion, Upper Extremity Insertion |
Primary outcome
Primary outcome is the presence of any complication which necessitates PICC removal
Time frame: Through study completion, within 4 weeks
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.
1 secondary outcome
Secondary outcome will be time to complication post insertion
Time frame: Through study completion, within 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amuchou Soraisham, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripherally Inserted Central Venous Cather (PICC) in people with Catheterization, Peripheral, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amuchou Soraisham, MD (403-944-8101, amuchou.soraisham@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome is the presence of any complication which necessitates PICC removal (time frame: Through study completion, within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023; AzTrials last refreshed its copy on 29 Oct 2026.