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Multiperfusion Neonatal System

Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05058534
Acronym
EDELWEISS
Enrollment
640
Registered
2021-09-27
Start date
2018-11-01
Completion date
2022-12-31
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Brief summary

Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. In critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. Sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. Late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter. In this context, a new multiperfusion device was developed (Multiline Néo®, Doran, France) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. But also to allow the administration of several drug solutions simultaneously avoiding contact between drugs. Our hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.

Interventions

DEVICEMultiline Neo®

Multiperfusion neonatal system

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Born between November 30, 2018 and December 31, 2022, * Gestational age below 33 weeks

Exclusion criteria

* Severe malformation and / or disease requiring heavy surgical management in the neonatal period * Admitted at croix rousse hospital after the third day of life

Design outcomes

Primary

MeasureTime frameDescription
Occurence of infectionthrough study completion, an average of 60 daysNumber of infections per 1000 catheter days, per patient during hospital stay

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026