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

University Hospital, Lille

Status: Terminated

Conditions: Bacteremia; Infant, Very Low Birth Weight

Treatments: Device: Standard Infusion Set; Device: Edelvaiss Multiline NEO

Study type: Interventional

Funder types: Other

Identifiers

NCT02633124

2015-A00585-44 (Other Identifier)

2014_67

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 24 to 29 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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87 participants in 2 patient groups

Edelvaiss Multiline NEO

Experimental group

Description:

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.

Treatment:

Device: Edelvaiss Multiline NEO

Standard Infusion Set

Other group

Description:

The infusion set used for the standard group is the infusion set usually used.

Treatment:

Device: Standard Infusion Set