Multiperfusion Neonatal System

Preterm Birth Clinical Trial

— EDELWEISS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058534
• Other study ID #: CRC_GHN_2021_004
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 31, 2022
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Device:
• Multiline Neo®
Multiperfusion neonatal system

Locations

Country	Name	City	State
France	Hospices Civil de Lyon	Lyon	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of infection	Number of infections per 1000 catheter days, per patient during hospital stay	through study completion, an average of 60 days