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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bacteremia, Infant, Very Low Birth Weight

Intervention / Treatment
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* Device: Edelvaiss Multiline NEO
* Device: Standard Infusion Set


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 29 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edelvaiss Multiline NEO<br>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<br>* Use of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period<br>|
| Other: Standard Infusion Set<br>The infusion set used for the standard group is the infusion set usually used. | Device: Standard Infusion Set<br>* Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of incidence density (ID) of catheter-related bacteremia (CRB) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature infants, Catheter-related bacteremia, Infusion device, Neonatal intensive care, Central Venous Catheter, Drug Infusion Systems