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Clinical Trials/NCT05058534
NCT05058534
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country640 target enrollmentNovember 1, 2018
ConditionsPreterm Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Hospices Civils de Lyon
Enrollment
640
Locations
1
Primary Endpoint
Occurence of infection
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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