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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00585-44 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edelvaiss Multiline NEO | Experimental | 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. |
|
| Standard Infusion Set | Other | The infusion set used for the standard group is the infusion set usually used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edelvaiss Multiline NEO | Device | Use of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Storme, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens Picardie | Amiens | France | ||||
| Hôpital Côte de Nacre - CHU de Caen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30744679 | Background | 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. | |
| 11358467 |
| Label | URL |
|---|---|
| Website of the Multiline NEO manufacturer (Doran International) | View source |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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| Standard Infusion Set | Device | Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period |
|
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 :
| Through an average of 30 days |
| Caen |
| France |
| Hôpital Jeanne de Flandre - CHRU de Lille | Lille | France |
| Hôpital Charles Nicolle - CHU de Rouen | Rouen | France |
| 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. |
| 25986020 | Result | 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. |
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |