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Completed

NCT Number: NCT05058534

Multiperfusion Neonatal System

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civil de Lyon

Lyon, Auvergne-Rhône-Alpes, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiline Neo®

Device

Multiperfusion neonatal system

Primary outcomes

  1. Occurence of infection

    Time frame: through study completion, an average of 60 days

    Number of infections per 1000 catheter days, per patient during hospital stay

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: EDELWEISS

Important dates

Study start
2018
Primary completion
2018
Study completion
2022
First posted
Sep 27, 2021
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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