Multiperfusion Neonatal System (EDELWEISS)
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|ClinicalTrials.gov Identifier: NCT05058534|
Recruitment Status : Recruiting
First Posted : September 27, 2021
Last Update Posted : September 27, 2021
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.
|Condition or disease||Intervention/treatment|
|Preterm Birth||Device: Multiline Neo®|
|Study Type :||Observational|
|Estimated Enrollment :||640 participants|
|Official Title:||Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||November 1, 2018|
|Estimated Study Completion Date :||December 31, 2022|
Very preterm infants born between November 30, 2018 and November 30, 2019
Infants born between November 30, 2018 - November 30, 2019, before implementation of the new multiperfusion neonatal system
Very preterm infants born between December 1st, 2019 and December 31st, 2022
Infants born between January 1rst, 2019 - December 31st, 2022, after implementation of the new multiperfusion neonatal system
Device: Multiline Neo®
Multiperfusion neonatal system
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058534
|Contact: Jean Claude Picaud, Premail@example.com|
|Hospices Civil de Lyon||Recruiting|
|Lyon, Rhone Alpes, France, 69004|
|Contact: Jean Claude Picaud, Pr +33472001550 firstname.lastname@example.org|