About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Ultrasound-Guided Long Peripheral Intravenous Catheter
- Short Peripheral Intravenous Catheter (Conventional Technique)