Multiperfusion Neonatal System (EDELWEISS)

Civil Hospices of Lyon

Status

Completed

Conditions

Preterm Birth

Treatments

Device: Multiline Neo®

Study type

Observational

Funder types

Other

Identifiers

NCT05058534

CRC_GHN_2021_004

Details and patient eligibility

About

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.

Enrollment

640 patients

Sex

All

Volunteers

No Healthy Volunteers

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