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Interest of Peripheral Venous Catheter Insertion Using a Micro-guide in Neonatology (EASYCATH)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Enrolling

Conditions

Newborns
Neonatology
Intensive Care

Treatments

Device: Insertion of peripheral venous catheter with micro-guide
Other: Classic insertion of peripheral venous catheter, without micro-guide

Study type

Interventional

Funder types

Other

Identifiers

NCT04984967
RECHMPL20_0410

Details and patient eligibility

About

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.

Enrollment

116 estimated patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

116 participants in 2 patient groups

Insertion of peripheral venous catheter with micro-guide
Experimental group
Treatment:
Device: Insertion of peripheral venous catheter with micro-guide
Classic insertion of peripheral venous catheter, without micro-guide
Other group
Treatment:
Other: Classic insertion of peripheral venous catheter, without micro-guide

Trial contacts and locations

1

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Central trial contact

Gilles CAMBONIE; Vincent BRODEAU

Data sourced from clinicaltrials.gov

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