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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Preterm Birth Device: Multiline Neo®

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Study Type : Observational
Estimated Enrollment : 640 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants born between November 30, 2018 and December 31, 2022, at a gestational age below 33 weeks, and hospitalized in the Neonatal unit of Croix-Rousse hospital
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jean Claude Picaud, Pr +33472001550 jean-claude.picaud@chu-lyon.fr

Locations
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France
Hospices Civil de Lyon Recruiting
Lyon, Rhone Alpes, France, 69004
Contact: Jean Claude Picaud, Pr    +33472001550    jean-claude.picaud@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT05058534    
Other Study ID Numbers: CRC_GHN_2021_004
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual participant data will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications