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.
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.
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).
Parallel
Ultrasound-Guided Long Peripheral Intravenous Catheter
Procedure/SurgeryParticipants in the intervention group will undergo ultrasound-guided insertion of a long peripheral intravenous catheter, performed by nurses from the Vascular Access Program. A portable ultrasound system with a high-frequency linear transducer (6-13 MHz), suitable for visualization of superficial vessels in neonates, will be used. Long peripheral intravenous catheters available at the institution will be used, in sizes 24G (32 mm) and 22G (64 mm), composed of radiopaque polyurethane and indicated for ultrasound-guided insertion. Procedures will follow institutional protocols for ultrasound-guided peripheral venous access and device selection. A maximum of four insertion attempts per participant will be allowed, with up to two attempts performed by one professional and, if necessary, two additional attempts by another nurse from the Vascular Access Program.
Short Peripheral Intravenous Catheter (Conventional Technique)
Procedure/SurgeryParticipants in the control group will undergo insertion of a short peripheral intravenous catheter using the conventional technique (visualization and palpation), performed by bedside nurses from the Neonatology Service. Short peripheral intravenous catheters available at the institution will be used, in sizes 24G (19 mm) and 22G (25 mm), composed of radiopaque polyurethane and intended for single-use peripheral venous access. Procedures will follow institutional protocols for conventional peripheral venous access and device selection. A maximum of four insertion attempts per participant will be allowed, with up to two attempts performed by one professional and, if necessary, two additional attempts by another bedside neonatal nurse.
Functional Catheter Dwell Time
Time (in hours) from successful catheter insertion to device removal for any reason, excluding planned removal at completion of antibiotic therapy.
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