NCT06656104: EDELVAISS

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

Recruiting now Last updated 22 January 2025

What this trial tests

trial testing Reference strategy in Neonatal Infection in 455 participants. Currently enrolling.

Timeline

14 January 2025

Primary endpoint
1 November 2026

1 November 2026

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	455
Start date	14 January 2025
Primary completion	1 November 2026
Estimated completion	1 November 2026
Sites	3 locations across France

Drugs / interventions tested

• Reference strategy
• Experimental strategy

Conditions studied

• Neonatal Infection — all drugs for Neonatal Infection →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Under 32 Weeks, any sex, with Neonatal Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The management of premature infants hospitalized in neonatal units requires the simultaneous intravenous (IV) infusion of several drugs and parenteral nutrition solutions, when oral administration is impossible or unsuitable. IV administration requires the use of a central venous catheter and an infusion set that connects the catheter to the infusion fluid or drug. The use of multiple infusion devices exposes patients to central line-associated bloodstream infections (CLABSI), drug interactions, abnormal administration timing and repetition of procedures in close proximity to the infant.

Against this backdrop, DORAN INTERNATIONAL has developed the EDELVAISS multi-infusion strategy (Multiline Neo® and Escape Line® devices) adapted to neonatology. Given its characteristics, the benefits expected from the use of this strategy are: 1) to reduce the risk of microbial contamination and therefore the number of nosocomial infections 2) reduce exposure to antibiotics used in late sepsis 3) reduce the number of central line losses due to catheter obstruction 4) reduce dys-stimulating procedures in contact with the infant and 5) reduce staff stress.

A pilot study before (year 2019) and after (year 2020) was carried out in the tertiary care neonatal unit at Croix-Rousse hospital. The baseline CLABSI rate was slightly below the national level of the last French survey (12.4/1000 catheter days \[95%CI:10.8;14.0\]). In 322 very-low-birth-weight infants, the investigators showed a significant 88% reduction in the rate of catheter-related bacteremia, from 11.3 to 2.2 infections per 1,000 catheter-days after implementation of the EDELVAISS multi-infusion strategy.

Since this pilot study, the EDELVAISS multi-infusion strategy has been used routinely in the neonatology department for around 2,000 infants admitted to the neonatology department at Croix-Rousse hospital. The low CLABSI rate observed in 2020 was maintained over the following 2 years. Several tertiary care neonatology departments have implemented the EDELVAISS multi-infusion strategy (ten departments have already done so, and five are in the process of doing so). The three neonatal units that agreed to take part in the EDELVAISS study also wish to implement the EDELVAISS multi-infusion strategy.

The invetsigators hypothesize that the reduction in CLABSI rates observed in the neonatal unit at Croix-Rousse hospital during the pilot study will be found in other French neonatal units, whatever the initial practices and devices used in each center.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.