Peripherally Inserted Central CatheterNCT07209670
Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort Study of Complications, Catheter Survival, and CLABSI"
An observational study of Peripherally Inserted Central Catheter and Umbilical Venous Catheter, run by Assiut University.
Trial summary
This study aims to prospectively compare umbilical venous catheters (UVCs) and peripherally inserted central catheters (PICCs) in neonates, focusing on complications, catheter survival, and central line-associated bloodstream infection (CLABSI) rates Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Peripherally Inserted Central Catheter, Umbilical Venous Catheter, CLABSI - Central Line Associated Bloodstream Infection
- What is being tested?
- peripherally inserted central catheter insertion and umbilical venous catheters insertion
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 20 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children's Hospital who require central venous access for parenteral nutrition, intravenous medications, or frequent blood sampling. Participants will include infants receiving either an umbilical venous catheter (UVC) or a peripherally inserted central catheter (PICC) within the first 28 days of life
Who may be able to join
- Neonates admitted to the neonatal intensive care unit (NICU) requiring central venous access.
- Infants in whom either an umbilical venous catheter (UVC) or a peripherally inserted central catheter (PICC) was inserted for clinical indications (Parenteral nutrition, administration of intravenous medications (e.g., antibiotics, inotropes, anticonvulsants, fluids) and blood sampling for frequent labs, especially in critically ill neonates).
- Catheter insertion performed within the first 28 days of life.
Who cannot join
- Neonates with major congenital anomalies (e.g.abdominal wall defects) that may interfere with catheter placement or outcomes.
- Insertion site infection
- Infants with severe coagulopathy or bleeding disorders contraindicating central catheter insertion.
- Neonates who received both UVC and PICC simultaneously during the same admission.
- Cases with incomplete clinical records or missing follow-up data.
About this study
This study aims to prospectively compare umbilical venous catheters (UVCs) and peripherally inserted central catheters (PICCs) in neonates, focusing on complications, catheter survival, and central line-associated bloodstream infection (CLABSI) rates
- Conditions
- Peripherally Inserted Central Catheter, Umbilical Venous Catheter, CLABSI - Central Line Associated Bloodstream Infection
- Being tested
- peripherally inserted central catheter insertion, umbilical venous catheters insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripherally inserted central catheter insertionProcedure or surgery
Neonates who received peripherally inserted central catheters within the first 28 days of life.
umbilical venous catheters insertionProcedure or surgery
Neonates who received umbilical venous catheters within the first 28 days of life
| Study group | Role | What they receive |
|---|---|---|
| UVC group | UVC Group: Neonates who received umbilical venous catheters within the first 28 days of life. Receives: Procedure: umbilical venous catheters insertion | |
| PICC group | PICC Group: Neonates who received peripherally inserted central catheters within the first 28 days of life. Receives: Procedure: peripherally inserted central catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
catheter survival time
Number of days each catheter remains functional and in use before removal
Measured: From catheter insertion until removal (up to 28 days of life or until hospital discharge, whichever occurs first)
Central Line-Associated Bloodstream Infection (CLABSI) Incidence
Number of CLABSI events per 1,000 catheter-days, diagnosed according to CDC/NHSN criteria (positive blood culture + clinical signs of sepsis with no other source)
Measured: During the entire catheterization period (up to 28 days of life or until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripherally Inserted Central CatheterStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Sayed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209670
- Sponsor's protocol ID
- venous catheters in neonates
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort Study of Complications, Catheter Survival, and CLABSI"
- ClinicalTrials.gov ID
- NCT07209670
- Acronym / sponsor ID
- venous catheters in neonates
- Conditions
- Peripherally Inserted Central Catheter, Umbilical Venous Catheter, CLABSI - Central Line Associated Bloodstream Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 7 Oct 2025 (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.
This study aims to prospectively compare umbilical venous catheters (UVCs) and peripherally inserted central catheters (PICCs) in neonates, focusing on complications, catheter survival, and central line-associated bloodstream infection (CLABSI) rates
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UVC group | – | Procedure: umbilical venous catheters insertionUVC Group: Neonates who received umbilical venous catheters within the first 28 days of life. |
| PICC group | – | Procedure: peripherally inserted central catheter insertionPICC Group: Neonates who received peripherally inserted central catheters within the first 28 days of life. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children's Hospital who require central venous access for parenteral nutrition, intravenous medications, or frequent blood sampling. Participants will include infants receiving either an umbilical venous catheter (UVC) or a peripherally inserted central catheter (PICC) within the first 28 days of life
Key inclusion criteria (3 listed)
- Neonates admitted to the neonatal intensive care unit (NICU) requiring central venous access.
Key exclusion criteria (5 listed)
- Neonates with major congenital anomalies (e.g.abdominal wall defects) that may interfere with catheter placement or outcomes.
- Insertion site infection
- Infants with severe coagulopathy or bleeding disorders contraindicating central catheter insertion.
- Neonates who received both UVC and PICC simultaneously during the same admission.
- Cases with incomplete clinical records or missing follow-up data.
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 |
|---|---|---|
| peripherally inserted central catheter insertionNeonates who received peripherally inserted central catheters within the first 28 days of life. | Procedure or surgery | PICC group |
| umbilical venous catheters insertionNeonates who received umbilical venous catheters within the first 28 days of life | Procedure or surgery | UVC group |
Primary outcome
catheter survival time
Time frame: From catheter insertion until removal (up to 28 days of life or until hospital discharge, whichever occurs first)
Number of days each catheter remains functional and in use before removal
Central Line-Associated Bloodstream Infection (CLABSI) Incidence
Time frame: During the entire catheterization period (up to 28 days of life or until hospital discharge
Number of CLABSI events per 1,000 catheter-days, diagnosed according to CDC/NHSN criteria (positive blood culture + clinical signs of sepsis with no other source)
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 7 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripherally Inserted Central Catheter and Umbilical Venous Catheter, run by Assiut University.
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 3 inclusion and 5 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 7 Oct 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catheter survival time (time frame: From catheter insertion until removal (up to 28 days of life or until hospital discharge, whichever occurs first)). The study lists 2 primary outcomes in all. 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 7 Oct 2025.