Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort… (NCT07209670) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort Study of Complications, Catheter Survival, and CLABSI"
360 participantsStarted 2025-12-01
Plain-language summary
This study aims to prospectively compare umbilical venous catheters (UVCs) and peripherally inserted central catheters (PICCs) in neonates, focusing on complications, catheter survival, and central line-associated bloodstream infection (CLABSI) rates
Who can participate
Age range
0 Days – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Neonates admitted to the neonatal intensive care unit (NICU) requiring central venous access.
* Infants in whom either an umbilical venous catheter (UVC) or a peripherally inserted central catheter (PICC) was inserted for clinical indications (Parenteral nutrition, administration of intravenous medications (e.g., antibiotics, inotropes, anticonvulsants, fluids) and blood sampling for frequent labs, especially in critically ill neonates).
* Catheter insertion performed within the first 28 days of life.
Exclusion Criteria:
* Neonates with major congenital anomalies (e.g.abdominal wall defects) that may interfere with catheter placement or outcomes.
* Insertion site infection
* Infants with severe coagulopathy or bleeding disorders contraindicating central catheter insertion.
* Neonates who received both UVC and PICC simultaneously during the same admission.
* Cases with incomplete clinical records or missing follow-up data.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
catheter survival time
Timeframe: From catheter insertion until removal (up to 28 days of life or until hospital discharge, whichever occurs first)
2
Central Line-Associated Bloodstream Infection (CLABSI) Incidence
Timeframe: During the entire catheterization period (up to 28 days of life or until hospital discharge