Ultrasound-Guided Long vs Short Peripheral IV Catheters in Neonates With Congenital Syphilis Rece… (NCT07568171) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ultrasound-Guided Long vs Short Peripheral IV Catheters in Neonates With Congenital Syphilis Receiving Antibiotics
104 participantsStarted 2026-05
Plain-language summary
Congenital syphilis in newborns requires intravenous antibiotic therapy, making reliable peripheral venous access essential. However, high rates of catheter failure and repeated punctures remain a significant clinical challenge. This randomized, controlled, parallel clinical trial aims to compare ultrasound-guided long peripheral intravenous catheters inserted by a specialized vascular access team with conventional short peripheral catheters inserted by neonatal nurses. A total of 104 newborns with congenital syphilis receiving intravenous penicillin will be randomly assigned to either group. The primary outcome is functional dwell time. Secondary outcomes include catheter failure, number of insertion attempts, first-attempt success, complications, and total number of devices required. The study hypothesizes that ultrasound-guided long peripheral catheters will improve vascular access outcomes, reduce complications, and minimize the need for repeated punctures.
Who can participate
Age range
1 Day – 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:
* Newborns admitted to the Neonatal Intermediate Care Unit;
* Diagnosis of congenital syphilis;
* Indication for intravenous penicillin therapy for an estimated duration of 10 days;
* Enrollment on the first day of treatment.
Exclusion Criteria:
* Newborns who have received any type of peripheral venous catheter prior to study enrollment;
* Clinical instability at the time of vascular access indication and/or requirement for admission to a Neonatal Intensive Care Unit;
* Requirement for concomitant administration of another antimicrobial agent in addition to crystalline penicillin;
* Need for catheter insertion outside the operating hours of the Vascular Access Program (7:00 AM to 7:00 PM, Monday to Friday).
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.