Actively Recruiting
Comparison of Two Techniques of Peripheral Venous Catheterization in Newborns: Insertion Using a Micro-guide Versus Conventional Insertion Without Micro-guide
Led by University Hospital, Montpellier · Updated on 2024-06-04
116
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Peripheral venous catheterization is commonly used to provide drug treatment, hydration, or anesthesia to newborns, including both term and preterm infants. However, in emergency situations, the first attempt to insert the peripheral venous catheter fails in about half of cases. Researchers aim to evaluate whether using a micro-guide can help guide the catheter more accurately into the vein, potentially reducing the risk of puncturing through the vessel wall during insertion. This study compares two techniques for inserting a peripheral venous catheter in newborns. One group uses a micro-guide device that is inserted after the vein is punctured with a needle, guiding the catheter placement before the guide is removed. The other group uses the classic method where the catheter is introduced directly with a needle and the needle is withdrawn while leaving the catheter in place. The trial randomly assigns participants to one of these two methods. Participants are newborns admitted to the neonatal and pediatric intensive care departments at Montpellier University Hospital. Researchers will assess the success of catheter insertion on the first attempt within five minutes, as the primary outcome. Secondary outcomes include the overall efficiency of the technique and any adverse events up to four days and one month after the procedure. The study monitors safety and effectiveness during the newborns' hospital stay and follows them for adverse events for up to one month.
CONDITIONS
Brief Title
Interest of Peripheral Venous Catheter Insertion Using a Micro-guide in Neonatology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborn admitted in the department of neonatal medicine and pediatric intensive care at Montpellier University Hospital
You will not qualify if you...
- Term neonate older than 28 days
- Premature neonate older than 41 weeks of corrected gestational age
- Exclusive requirement for an umbilical venous catheter in neonatal resuscitation
- Exclusive requirement for an epicutaneous-cava catheter in prolonged parenteral nutrition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 minutes after the success of the placement
Participants receive insertion of a peripheral venous catheter using either a micro-guide or the classic technique without a micro-guide.
1 procedure visit (in-person)
Duration - Up to 1 month
Participants are monitored for efficiency of the catheterization technique and adverse events.
Up to 4 follow-up visits over 1 month
Trial Site Locations
Total: 1 location
1
University Hospital Montpellier
Montpellier, France, 34295
Actively Recruiting
Research Team
G
Gilles CAMBONIE
V
Vincent BRODEAU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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