Multiperfusion Neonatal System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

Multiline Neo®

Intervention Type DEVICE

Multiperfusion neonatal system

Interventions

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Multiline Neo®

Multiperfusion neonatal system

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No