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

NCT07568171 | Not Yet Recruiting DMC

• 1 other identifier: 2026-0023
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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; Ultrasonography; Catheterization, Peripheral; Advanced Practice Nursing; Patient Safety; Neonatal Nursing

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 10 days

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

Ultrasound-guided insertion of a long peripheral intravenous catheter performed by nurses from the Vascular Access Program.

Procedure: Ultrasound-Guided Long Peripheral Intravenous Catheter

Control Group (CG)

ACTIVE COMPARATOR

Conventional insertion of a short peripheral intravenous catheter performed by bedside neonatal nurses.

Procedure: Short Peripheral Intravenous Catheter (Conventional Technique)

Interventions

Ultrasound-Guided Long Peripheral Intravenous Catheter PROCEDURE

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.

Intervention Group (IG)

Short Peripheral Intravenous Catheter (Conventional Technique) PROCEDURE

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.

Control Group (CG)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Syphilis, Congenital

Condition Hierarchy (Ancestors)

Syphilis; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Eneida R. Rabelo da Silva, ScD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eneida R. Rabelo da Silva, ScD

CONTACT

5551998068616; eneidarabelo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Prospective Randomized Open, Blinded End-point (PROBE Study)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share