Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.
NCT ID: NCT02633124
Last Updated: 2020-11-20
Study Results
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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TERMINATED
NA
87 participants
INTERVENTIONAL
2016-01-31
2020-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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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.
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.
Standard Infusion Set
Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period
Interventions
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Edelvaiss Multiline NEO
Use of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period
Standard Infusion Set
Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period
Eligibility Criteria
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Inclusion Criteria
* Infants carrying a single-lumen central venous catheter.
* Obtaining the informed parental consent.
Exclusion Criteria
* Infants carrying a umbilical venous catheter.
* Infants carrying two central venous catheters.
* Refusal of informed parental consent.
24 Weeks
29 Weeks
ALL
Yes
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Laurent Storme, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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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
Countries
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References
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Mahieu LM, De Dooy JJ, Lenaerts AE, Ieven MM, De Muynck AO. Catheter manipulations and the risk of catheter-associated bloodstream infection in neonatal intensive care unit patients. J Hosp Infect. 2001 May;48(1):20-6. doi: 10.1053/jhin.2000.0930.
Erdei C, McAvoy LL, Gupta M, Pereira S, McGowan EC. Is zero central line-associated bloodstream infection rate sustainable? A 5-year perspective. Pediatrics. 2015 Jun;135(6):e1485-93. doi: 10.1542/peds.2014-2523. Epub 2015 May 18.
Maiguy-Foinard A, Decaudin B, Tourneux P, Guillois B, Blanc T, Galene-Gromez S, Masse M, Odou P, Denies F, Dervaux B, Duhamel A, Storme L. Effect of multi-lumen perfusion line on catheter-related bacteremia in premature infants: study protocol for a cluster-randomized crossover trial. Trials. 2019 Feb 11;20(1):115. doi: 10.1186/s13063-019-3218-6.
Related Links
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Website of the Multiline NEO manufacturer (Doran International)
Other Identifiers
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2015-A00585-44
Identifier Type: OTHER
Identifier Source: secondary_id
2014_67
Identifier Type: -
Identifier Source: org_study_id