Using a micro-guide to insert catheters in newborns
Comparison of Two Techniques of Peripheral Venous Catheterization in Newborns : Insertion on Micro-guide Versus Conventional Insertion, Without Micro-guide
This study tests if using a special micro-guide can help doctors insert catheters into newborns more successfully during emergencies compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | N/A to 28 Days |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT04984967 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using a micro-guide for peripheral venous catheter insertion in newborns, particularly in emergency situations. The goal is to improve the success rate of catheterization, which currently fails about 50% of the time on the first attempt. By guiding the catheter into the vein, the micro-guide aims to reduce complications such as transfixion of the vascular lumen. The study compares this method to the traditional catheter insertion technique without a micro-guide.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns admitted to the neonatal medicine and pediatric intensive care unit at Montpellier University Hospital.
Not a fit: Patients who are term neonates older than 28 days or premature neonates older than 41 weeks of corrected gestational age may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the success rate of catheter insertions in newborns, leading to better patient outcomes.
How similar studies have performed: While similar approaches have been explored, the use of a micro-guide specifically for neonatal catheterization is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montpellier
- University Hospital Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Gilles CAMBONIE
- Email: g-cambonie@chu-montpellier.fr
- Phone: 04 67 33 65 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.