Actively Recruiting

Age: 0 - 32Weeks
All Genders
ID06656104

Impact of a Multi-infusion Device Strategy on Central Line Bloodstream Infections in Very Preterm Infants in Neonatal Units

Led by Hospices Civils de Lyon · Updated on 2025-01-22

455

Participants Needed

3

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of a new multi-infusion strategy on the rate of central line-associated bloodstream infections (CLABSI) in very preterm infants hospitalized in neonatal units. The study focuses on infants born at or before 32 weeks gestation and weighing 1600 grams or less. The purpose is to see if this strategy can reduce infections, antibiotic use, catheter problems, and stressful procedures compared to usual care. This approach builds upon a pilot study at Croix-Rousse hospital that showed promising reductions in infection rates using the EDELVAISS multi-infusion devices. The study compares two approaches: the routine reference strategy using usual catheters and infusion systems, and the experimental EDELVAISS multi-infusion strategy. This new method uses specialized devices designed for neonatal care to deliver multiple intravenous drugs and nutrition solutions safely and efficiently. The strategy aims to lower infection risks and improve care by minimizing line manipulations and device-related complications. Participants are very preterm infants admitted within the first three days of life who need infusion sets for multiple drugs or solutions. They will be monitored during their hospital stay, with researchers tracking infection rates up to six months. Data collection includes recording catheter-related bloodstream infections and observing catheter performance and complications. The study also involves parental consent and excludes infants with certain severe conditions or participation in conflicting studies. The total participation period depends on the infant's hospital stay and clinical course.

CONDITIONS

Official Title

Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections

Who Can Participate

Age: 0 - 32Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age at birth 64; 32 weeks
  • Birthweight 64; 1600 g
  • Admitted in the first 3 days of life in the neonatal unit
  • Hospitalized in the neonatal unit for at least 1 day
  • Survived the first three days of life
  • Requires the use of infusion sets for the administration of multiple drugs or solutions, whether or not they have the device in place
  • Receipt of the non-opposition from parents or guardians
Not Eligible

You will not qualify if you...

  • Opposition by parents or guardians
  • Lethal or complicated malformation
  • Chromosomal anomaly
  • Participation of the infant in any other research that may interfere with the results of this study, in the judgment of the investigator

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Service de néonatologie Hôpital Femme Mère Enfant

Bron, France, France, 69500

Actively Recruiting

2

Service Pédiatrie néonatale et réanimations CHU Montpellier

Montpellier, France, France, 34090

Not Yet Recruiting

3

Service de néonatologie CHU de Strasbourg

Strasbourg, France, France, 67091

Active, Not Recruiting

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Research Team

J

Jean-Charles PICAUD, MD, PhD

F

Fanny JOUBERT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Frequently Asked Questions

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Impact of a Multi-infusion Device Strategy on Central Line Bloodstream Infections in Very Preterm Infants in Neonatal Units | DecenTrialz