Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.
- Conditions
- BacteremiaInfant, Very Low Birth Weight
- Interventions
- Device: Edelvaiss Multiline NEODevice: Standard Infusion Set
- Registration Number
- NCT02633124
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 87
- Infants with gestational ages between 24 and 29 weeks.
- Infants carrying a single-lumen central venous catheter.
- Obtaining the informed parental consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Edelvaiss Multiline NEO 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. Standard Infusion Set Standard Infusion Set The infusion set used for the standard group is the infusion set usually used.
- Primary Outcome Measures
Name Time Method Measure of incidence density (ID) of catheter-related bacteremia (CRB) 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
Name Time Method Measure of ID of occlusion of components of the infusion system 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.
Number of septic shock 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.
Total duration of oxygen therapy 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.
Number of bronchopulmonary dysplasia 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.
Total duration of mechanical ventilation 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.
Total duration of parenteral nutrition 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.
Cost of care for patients 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.
Trial Locations
- Locations (4)
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
Chu Amiens Picardie🇫🇷Amiens, France