Comparison of Two Techniques of Peripheral Venous Catheterization in Newborns : Insertion on Micro-guide Versus Conventional Insertion, Without Micro-guide
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 116
- Locations
- 2
- Primary Endpoint
- Success of peripheral venous catheterization at the first attempt
Study Overview
Brief Summary
Peripheral venous catheterization represents the preferential option for term or preterm infant care in order to start drug treatment or hydration, or perform anesthesia.
However, the peripheral venous access is associated in approximately 50% of cases with a failure of the insertion on the first attempt in an emergency context. Using a micro-guide may facilitate the peripheral venous catheterization in newborns, by guiding the catheter in the vein and, thereby reduce the risk of transfixion of the vascular lumen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Masking Description
Peripheral venous catheterization is perform by a nurse. The placement characteristics are evaluated by the investigator, blind of the condition of placement if possible.
Eligibility Criteria
- Ages
- — to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital
Exclusion Criteria
- •Term neonate > 28 days
- •Premature neonate > 41 weeks of corrected gestational age
- •Exclusive requirement for an umbilical venous catheter, in the context of neonatal resuscitation
- •Exclusive requirement for an epicutaneous-cava catheter, in the context of prolonged parenteral nutrition.
Outcomes
Primary Outcomes
Success of peripheral venous catheterization at the first attempt
Time Frame: Up to 5 minutes after the success of the placement
The success of the placement is defined by the arrival of blood in the transparent chamber downstream of the needle during the placement, and by the absence of painful reaction and edema near the insertion site, indicating extravasation or extravascular passage, after flushing the catheter with 0.5 to 1 ml of isotonic saline. The success will be confirmed by retesting flush after securing the peripheral venous catheter in a dressing, within 3 to 5 minutes of successful puncture.
Secondary Outcomes
- Adverse events(Up to 1 month.)
- Efficiency of the technique(Up to 4 days.)