Infant, NewbornULTRA-ACCESSNCT07568171
Ultrasound-Guided Long vs Short Peripheral IV Catheters in Neonates With Congenital Syphilis Receiving Antibiotics
A study testing Ultrasound-Guided Long Peripheral Intravenous Catheter and Short Peripheral Intravenous Catheter (Conventional Technique) in people with Infant, Newborn and Syphilis, Congenital, run by Hospital de Clinicas de Porto Alegre.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Infant, Newborn, Syphilis, Congenital, Catheterization, Peripheral
- What is being tested?
- Ultrasound-Guided Long Peripheral Intravenous Catheter and Short Peripheral Intravenous Catheter (Conventional Technique)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
Data will be collected prospectively using standardized forms, and outcome assessment will be performed by trained personnel not directly involved in catheter insertion. Statistical analysis will follow the intention-to-treat principle, and results will be reported in accordance with CONSORT guidelines.
It is hypothesized that ultrasound-guided long peripheral intravenous catheters will result in longer functional dwell time, fewer failures, and reduced need for repeated punctures, contributing to improved vascular preservation, enhanced patient safety, reduced neonatal pain and stress, and more efficient use of healthcare resources.
- Conditions
- Infant, Newborn, Syphilis, Congenital, Catheterization, Peripheral, Ultrasonography, Advanced Practice Nursing, Patient Safety
- Being tested
- Ultrasound-Guided Long Peripheral Intravenous Catheter, Short Peripheral Intravenous Catheter (Conventional Technique)
- Medical subject headings
- Syphilis, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Long Peripheral Intravenous CatheterProcedure or surgery
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.
Short Peripheral Intravenous Catheter (Conventional Technique)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Ultrasound-guided insertion of a long peripheral intravenous catheter performed by nurses from the Vascular Access Program. Receives: Procedure: Ultrasound-Guided Long Peripheral Intravenous Catheter |
| Control | Active comparator | Conventional insertion of a short peripheral intravenous catheter performed by bedside neonatal nurses. Receives: Procedure: Short Peripheral Intravenous Catheter (Conventional Technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startMay 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eneida R. Rabelo da Silva, ScD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568171
- Sponsor's protocol ID
- 2026-0023
- Acronym
- ULTRA-ACCESS
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07568171
- Acronym / sponsor ID
- ULTRA-ACCESS / 2026-0023
- Conditions
- Infant, Newborn, Syphilis, Congenital, Catheterization, Peripheral, Ultrasonography, Advanced Practice Nursing, Patient Safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Data will be collected prospectively using standardized forms, and outcome assessment will be performed by trained personnel not directly involved in catheter insertion. Statistical analysis will follow the intention-to-treat principle, and results will be reported in accordance with CONSORT guidelines.
It is hypothesized that ultrasound-guided long peripheral intravenous catheters will result in longer functional dwell time, fewer failures, and reduced need for repeated punctures, contributing to improved vascular preservation, enhanced patient safety, reduced neonatal pain and stress, and more efficient use of healthcare resources.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Ultrasound-Guided Long Peripheral Intravenous CatheterUltrasound-guided insertion of a long peripheral intravenous catheter performed by nurses from the Vascular Access Program. |
| Control | Active comparator | Procedure: Short Peripheral Intravenous Catheter (Conventional Technique)Conventional insertion of a short peripheral intravenous catheter performed by bedside neonatal nurses. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Long Peripheral Intravenous CatheterParticipants 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 or surgery | Intervention |
| 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. | Procedure or surgery | Control |
Primary outcome
Functional Catheter Dwell Time
Time frame: Up to 10 days
Time (in hours) from successful catheter insertion to device removal for any reason, excluding planned removal at completion of antibiotic therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eneida R. Rabelo da Silva, ScD principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Long Peripheral Intravenous Catheter and Short Peripheral Intravenous Catheter (Conventional Technique) in people with Infant, Newborn and Syphilis, Congenital, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eneida R. Rabelo da Silva, ScD (5551998068616, eneidarabelo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Catheter Dwell Time (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.