Actively Recruiting

Phase Not Applicable
Age: 0 - 28Days
All Genders
ID04984967

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 The other group uses the classic method where the catheter is introduced directly with a needle and the needle is withdrawn while leaving the catheter in place.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

Age: 0 - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborn admitted in the department of neonatal medicine and pediatric intensive care at Montpellier University Hospital
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

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)

Post-operative Follow-up

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

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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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