Multiperfusion Neonatal System

Completed

• Conditions: Preterm Birth
• Interventions: Device: Multiline Neo®

• Registration Number: NCT05058534
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2018-11-01
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-09-27
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

• Born between November 30, 2018 and December 31, 2022,
• Gestational age below 33 weeks

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Very preterm infants born between December 1st, 2019 and December 31st, 2022	Multiline Neo®	Infants born between January 1rst, 2019 - December 31st, 2022, after implementation of the new multiperfusion neonatal system

Primary Outcome Measures

Name	Time	Method
Occurence of infection	through study completion, an average of 60 days	Number of infections per 1000 catheter days, per patient during hospital stay

Trial Locations

Locations (1)

Hospices Civil de Lyon; 🇫🇷 Lyon, Rhone Alpes, France