Clinical trial NCT02633124: Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.
Official title: Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants: Randomized Controlled Multicenter Study of Edelvaiss Multiline NEO Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bacteremia
Infant, Very Low Birth Weight
Keywords: Premature infants
Catheter-related bacteremia
Infusion device
Neonatal intensive care
Central Venous Catheter
Drug Infusion Systems
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2015-12-17
Enrollment: 87
Sex: ALL
Minimum age (years): 24
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Measure of incidence density (ID) of catheter-related bacteremia (CRB)
timeFrame: Through an average of 30 days
Secondary outcomes:
measure: Measure of ID of occlusion of components of the infusion system
timeFrame: Through an average of 30 days
measure: Number of septic shock
timeFrame: Through an average of 30 days
measure: Total duration of oxygen therapy
timeFrame: Through an average of 30 days
measure: Total duration of mechanical ventilation
timeFrame: Through an average of 30 days
measure: Total duration of parenteral nutrition
timeFrame: Through an average of 30 days
measure: Number of bronchopulmonary dysplasia
timeFrame: Through an average of 30 days
measure: Cost of care for patients
timeFrame: Through an average of 30 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Caen
country: France
facility: Hôpital Côte de Nacre - CHU de Caen
city: Lille
country: France
facility: Hôpital Jeanne de Flandre - CHRU de Lille
city: Rouen
country: France
facility: Hôpital Charles Nicolle - CHU de Rouen
Study officials:
affiliation: University Hospital, Lille
name: Laurent Storme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.