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临床试验/NCT07568171
NCT07568171尚未招募不适用

Ultrasound-Guided Long Peripheral Intravenous Catheters Versus Conventional Short Peripheral Catheters for Reducing Post-Insertion Failure in Neonates With Congenital Syphilis Receiving Antibiotic Therapy: A Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre0 个研究点目标入组 104 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
104

研究概览

简要总结

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.

详细描述

Congenital syphilis remains a significant public health problem and requires prolonged intravenous antibiotic therapy, typically with crystalline penicillin. In this context, reliable peripheral venous access is essential to ensure treatment continuity and safety. However, vascular access in newborns is particularly challenging due to small vessel caliber, tissue fragility, and increased susceptibility to complications, often resulting in high rates of catheter failure and repeated insertion attempts.

Short peripheral intravenous catheters inserted using conventional techniques are the most commonly used devices in neonatal care. Despite their widespread use, these devices are associated with limited dwell time and a higher likelihood of failure. Current guidelines recommend the use of adjunct technologies, such as ultrasound guidance, as well as devices with longer dwell times to improve vascular access outcomes. Ultrasound-guided insertion allows better visualization of vessels, potentially increasing first-attempt success and reducing complications. In addition, long peripheral intravenous catheters may provide greater stability and prolonged functional use compared with short catheters.

This study is a randomized, controlled, parallel, prospective clinical trial designed to compare ultrasound-guided long peripheral intravenous catheters inserted by a specialized vascular access team with conventional short peripheral catheters inserted by neonatal nurses. The study will be conducted in the Neonatal Intermediate Care Unit of the Hospital de Clínicas de Porto Alegre, Brazil, between May 2026 and March 2028.

Eligible participants are newborns diagnosed with congenital syphilis who require intravenous antibiotic therapy with crystalline penicillin for a planned duration of ten days. After enrollment, participants will be randomly assigned to either the intervention group (ultrasound-guided long peripheral intravenous catheter) or the control group (short peripheral catheter inserted using conventional technique).

The primary outcome is functional catheter dwell time, defined as the duration from catheter insertion to removal due to completion of therapy or occurrence of failure. Secondary outcomes include catheter failure, number of insertion attempts, first-attempt success, incidence of complications (such as infiltration, extravasation, obstruction, and phlebitis), and total number of devices required during treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Prospective Randomized Open, Blinded End-point (PROBE Study)

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究者

申办方类型
Other
责任方
Sponsor

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