Ultrasound-Guided Long vs Short Peripheral IV Catheters in Neonates With Congenital Syphilis Receiving Antibiotics

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.

Conditions

• Infant, Newborn
• Syphilis, Congenital
• Catheterization, Peripheral
• Ultrasonography
• Advanced Practice Nursing
• Patient Safety
• Neonatal Nursing

Interventions

PROCEDURE

Ultrasound-Guided Long Peripheral Intravenous Catheter

Participants 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.

PROCEDURE

Short Peripheral Intravenous Catheter (Conventional Technique)

Participants 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• Eneida R. Rabelo da Silva, ScD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

28 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2028-03-31

Completion

2028-12-31