NCT02633124

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 24 Weeks – 29 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Bacteremia
• Infant, Very Low Birth Weight

Interventions

Type	Name	Description
DEVICE	Edelvaiss Multiline NEO	Use of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period
DEVICE	Standard Infusion Set	Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2015-12-17
• Last updated: 2020-11-20

Locations

4 sites across 1 country: France