Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants. (MultilineNEO)

November 19, 2020 updated by: University Hospital, Lille

Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants: Randomized Controlled Multicenter Study of Edelvaiss Multiline NEO Device

This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants. This device will be compared to the standard infusion set of each center.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Edelvaiss® Multiline NEO is a multi-lumen infusion access device, adapted to the neonatal population. It has five ports connected to five lumens separated in a single tube of 90 cm, combined with a small single tube called annex port. Four ports numbered 1 to 4 are connected to four peripheral lumens (residual volume per lumen: 0.6 mL). The fifth port, called central access (indicated by the HF icon (High Flow)), is reserved to the administration of parenteral nutrition. It is connected to the central lumen (residual volume: 4.5 mL). The sixth port on the annex way allows an administration closer to the infant (residual volume: 0.40 mL). It is thus reserved for emergencies and direct intravenous injections.

The innovative technological design of Edelvaiss® Multiline NEO device should enable secure administration of injectable drugs by preventing variations in drug mass flow rate and the occurrence of drug incompatibilities. This device would reduce the number of perfusion incidents and therefore, the frequency of manipulations of infusion lines within the incubator, direct source of occurrence of bacteremia.

Moreover, its main interest lies in neonatology in the possibility of being positioned outside of the incubator and to have a lifetime of 21 days, contributing to the prevention of catheter-related bacteremia. All manipulations are therefore made outside the incubator at the room temperature and the relative humidity, and at a distance from the device/catheter junction.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU Amiens Picardie
      • Caen, France
        • Hôpital Côte de Nacre - CHU de Caen
      • Lille, France
        • Hôpital Jeanne de Flandre - CHRU de Lille
      • Rouen, France
        • Hôpital Charles Nicolle - CHU de Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants with gestational ages between 24 and 29 weeks.
  • Infants carrying a single-lumen central venous catheter.
  • Obtaining the informed parental consent.

Exclusion Criteria:

  • Infants carrying a multi-lumen central venous catheter.
  • Infants carrying a umbilical venous catheter.
  • Infants carrying two central venous catheters.
  • Refusal of informed parental consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Edelvaiss Multiline NEO
The Edelvaiss Multiline NEO design allows to position the access to the infusion line outside of the incubator, without increasing the residual volume and this device has been validated by the manufacturer as part of CE marking for a period of 21 days.
Device: Edelvaiss Multiline NEO
Use of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period
Other: Standard Infusion Set
The infusion set used for the standard group is the infusion set usually used.
Device: Standard Infusion Set
Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of incidence density (ID) of catheter-related bacteremia (CRB)
Time Frame: Through an average of 30 days

Catheter-related bacteremia (CRB) are the most frequent nosocomial infections in Neonatal Intensive Care Unit (NICU) patients. Nosocomial CRB in the NICU contribute significantly to hospital morbidity as well as to increased costs due to prolonged hospitalization.

The main objective is to assess the interest of the Multiline NEO in preventing CRB when administering injectable medications in NICU patients. It is whether the Multiline NEO device reduces the risk of CRB in premature infants hospitalized in NICU.

Measure of ID of CRB as criteria of Neocat Network during central venous catheterization in the patient.
Through an average of 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of ID of occlusion of components of the infusion system
Time Frame: Through an average of 30 days
Measure of ID of occlusion of components of the infusion system is determined on the period of central venous catheterization in the patient.
Through an average of 30 days
Number of septic shock
Time Frame: Through an average of 30 days
The number of septic shock defined by the use of vasoactive drugs during central venous catheterization in the patient.
Through an average of 30 days
Total duration of oxygen therapy
Time Frame: Through an average of 30 days
Total duration of oxygen therapy is determined from the inclusion of the patient in the study until the end of his hospitalization.
Through an average of 30 days
Total duration of mechanical ventilation
Time Frame: Through an average of 30 days
Total duration of mechanical ventilation is determined from the inclusion of the patient in the study until the end of his hospitalization.
Through an average of 30 days
Total duration of parenteral nutrition
Time Frame: Through an average of 30 days
Total duration of parenteral nutrition is determined from the inclusion of the patient in the study until the end of his hospitalization.
Through an average of 30 days
Number of bronchopulmonary dysplasia
Time Frame: Through an average of 30 days
Number of bronchopulmonary dysplasia defined by the Walsh test is determined from the inclusion of the patient in the study until the end of his hospitalization.
Through an average of 30 days
Cost of care for patients
Time Frame: Through an average of 30 days

Cost of care for patients includes :

  • cost of components of the infusion lines, including their replacement,
  • cost of nursing time dedicated to handling lines,
  • cost of identifying a CRB,
  • cost of hospital stay. Cost of care for a patient is calculated from the inclusion of the patient in the study until the end of his hospitalization.
Through an average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Laurent Storme, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014_67
  • 2015-A00585-44 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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