Multiperfusion Neonatal System

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    640
  • sponsor
    Hospices Civils de Lyon
Updated on 4 October 2021

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 No, 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.

Details
Condition preterm delivery, premature delivery, preterm birth, Pre-Term, Premature, Premature Birth
Treatment Multiline Neo®
Clinical Study IdentifierNCT05058534
SponsorHospices Civils de Lyon
Last Modified on4 October 2021

Eligibility

Yes No Not Sure

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
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