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

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ClinicalTrials.gov Identifier: NCT02633124
Recruitment Status : Terminated
First Posted : December 17, 2015
Last Update Posted : November 20, 2020
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacteremia Infant, Very Low Birth Weight Device: Edelvaiss Multiline NEO Device: Standard Infusion Set Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants: Randomized Controlled Multicenter Study of Edelvaiss Multiline NEO Device
Actual Study Start Date : January 2016
Actual Primary Completion Date : May 2020
Actual Study Completion Date : May 2020

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

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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   24 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02633124


Locations
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France
Chu Amiens Picardie
Amiens, France
Hôpital Côte de Nacre - CHU de Caen
Caen, France
Hôpital Jeanne de Flandre - CHRU de Lille
Lille, France
Hôpital Charles Nicolle - CHU de Rouen
Rouen, France
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Laurent Storme, MD, PhD University Hospital, Lille
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02633124    
Other Study ID Numbers: 2014_67
2015-A00585-44 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Premature infants
Catheter-related bacteremia
Infusion device
Neonatal intensive care
Central Venous Catheter
Drug Infusion Systems
Additional relevant MeSH terms:
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Bacteremia
Premature Birth
Birth Weight
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Body Weight
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes